Product code JJY— Clinical Chemistry
AMERLITE FREE THYROID CONTROL SERA LAN.4002
- Classification name
- Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Total cleared
- 673
- First cleared
- Most recent
Market context for product code JJY
FDA has cleared devices under product code JJY between 1976 and 2017, filed by 167 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
Top applicants under product code JJY
Recent clearances under product code JJY
1–100 of 673- K162530 — Multichem IA Plus
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150300 — Liquichek Cardiac Markers Plus Control LT
- K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit
- K143379 — Liquichek Maternal Serum II Control
- K143573 — Audit MicroControls Linearity FD Tumor Markers II
- K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
- K142978 — Audit MicroControls Linearity LQ Special Diabetes
- K133676 — ABX PENTRA MICRO ALB CONTROL L/H
- K141073 — LIQUICHEK TUMOR MARKER CONTROL
- K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
- K140916 — LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
- K140764 — LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
- K134013 — LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
- K140393 — RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
- K133960 — LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
- K132227 — LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
- K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3
- K132751 — MULTICHEM S PLUS / S PLUS (ASSAYED)
- K131993 — MULTICHEM U
- K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL
- K131992 — MULTICHEM P
- K132091 — MULTICHEM IA AND IA PLUS
- K131595 — EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
- K130337 — RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
- K130963 — LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
- K130762 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
- K124009 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
- K130761 — LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
- K123725 — FASTPACK CONTROL KIT
- K130162 — LIQUID ASSAYED MULTIQUAL PREMIUM
- K123775 — LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
- K123663 — LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
- K121603 — RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
- K123198 — LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
- K122838 — LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
- K113720 — RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
- K122291 — THERMO SCIENTIFIC MAS OMNI-CARDIO
- K121759 — CONE-TROL LIQUID CHEMISTRY CONTROLS
- K121794 — LIQUICHEK URINE CHEMISTRY CONTROL
- K121468 — EUROTROL GAS-ISE METABOLITES
- K112742 — AUDIT MICROLQ SPINAL FLUID CONTROL
- K111964 — AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
- K112705 — AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
- K110534 — RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
- K112337 — RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
- K101863 — IT/IF CONTROL
- K110738 — THERMO SCIENTIFIC MAS OMNI-CORE
- K110904 — RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
- K111996 — ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
- K111506 — ELECSYS PRECICONTROL VARIA 3
- K110880 — VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
- K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
- K111063 — VITAL SERUM CONTROLS
- K103601 — AUDIT MICROCV IMMUNOASSAY LINEARITY SET
- K103364 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
- K103271 — MSC LIPID CONTROL
- K101216 — AUDIT MICROCV PROTEIN LINEARITY SET
- K102617 — AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
- K102700 — LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
- K101809 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
- K100727 — LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
- K100718 — AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
- K102016 — PRECICONTROL CLINCHEM MULTI 1 AND 2
- K101226 — AUDIT MICROCV RF/CRP LINEARITY SET
- K101633 — NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
- K102157 — ELECSYS PRECICONTROL MULTIMARKER
- K093492 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR
- K093384 — MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
- K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
- K092320 — ELECSYS PRECICONTROL THYROAB
- K092051 — THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
- K090541 — ELECSYS PRECICONTROL UNIVERSAL
- K091225 — VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
- K083554 — CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
- K090475 — VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
- K083891 — VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
- K082714 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
- K082717 — AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
- K082107 — CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
- K082036 — LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
- K082067 — MSC LIPID CONTROL
- K080973 — CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
- K073080 — QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
- K072835 — LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
- K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
- K072246 — VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
- K071980 — DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
- K071675 — LIQUICHEK TUMOR MARKER CONTROL
- K071433 — SMS GLUCOSE CONTROL, MODEL 2120059
- K070741 — CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
- K070504 — AMMONIA/ALCOHOL CONTROL SET
- K070200 — TDM CONTROL SET, MODEL CAT# 04521536
- K070223 — AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
- K062379 — COBAS INTEGRA CERULOPLASMIN
- K062674 — MISSION TRINITY B
- K062593 — CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
- K062916 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3
Data sourced from openFDA. This site is unofficial and independent of the FDA.