Product code JIT— Clinical Chemistry
CALIBRATING MATERIAL, CALIBRATING STANDARDS
- Classification name
- Calibrator, Secondary
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Total cleared
- 245
- First cleared
- Most recent
Market context for product code JIT
FDA has cleared devices under product code JIT between 1976 and 2017, filed by 94 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
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 JIT
Recent clearances under product code JIT
1–100 of 245- K171168 — VITROS Immunodiagnostic Products Insulin Calibrators
- K170938 — CalSet IGF-1
- K170160 — Abbott ARCHITECT Free T3
- K163534 — Lumipulse G FSH-N Calibrators
- K163546 — Lumipulse G Progesterone-N Calibrators
- K163521 — Lumipulse G LH Calibrators
- K163544 — Lumipulse G Prolactin
- K163078 — DC-UIBC-CAL
- K163053 — Lumipulse G E2-III Calibrators
- K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
- K160113 — ST AIA-PACK hsE2 Calibrator Set
- K153417 — ST AIA-PACK PROG III Calibrator Set
- K152526 — Elecsys Progesterone III CalSet
- K151566 — Abbott ARCHITECT Total T4 Calibrators
- K142985 — UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
- K143342 — Elecsys T-Uptake Calset
- K143144 — ST AIA-PACK PROG II Calibrator Set
- K142181 — RANDOX ALDOLASE CALIBRATION SERUM
- K142021 — Elecsys Estradiol III CalSet
- K133751 — DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
- K141728 — ACE CALIBRATOR
- K141374 — BICARBONATE CALIBRATOR
- K140112 — CA 125 II CALSET II
- K140648 — ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
- K130603 — PATHFAST CTNL CALIBRATORS
- K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS
- K130628 — PATHFAST CK-MB-II CALIBRATORS
- K131556 — DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
- K130698 — DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
- K122177 — ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
- K121027 — DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
- K120591 — DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
- K113373 — DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
- K111952 — ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
- K111762 — ST AIA-PACK DHEA-S CALIBRATOR SET
- K111023 — ABBOTT ARCHITECT LH CALIBRATORS
- K103548 — ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
- K110169 — DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
- K103836 — ENZYME II CALIBRATOR
- K103221 — ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
- K103360 — DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
- K102638 — DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
- K092937 — STA-HYBRID HEP CALIBRATOR
- K093357 — DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
- K100293 — ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810
- K092570 — ABX PENTRA TPU CAL, MODEL A11A01898
- K083462 — DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
- K082680 — LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
- K081789 — DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
- K082141 — ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
- K081319 — DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
- K081683 — LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
- K080166 — ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
- K072717 — DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
- K071039 — MISSION OLYMPUS AU ISE CALIBRATORS
- K070552 — DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
- K062521 — OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
- K070144 — INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K060854 — ABX PENTRA 400: LIPOPROTEINS
- K062152 — CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
- K061885 — DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
- K061818 — DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
- K061751 — DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
- K061702 — DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
- K061139 — BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
- K061282 — ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
- K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
- K060754 — ELECSYS TSH CALSET W/MODELS 04738551
- K060359 — ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
- K060322 — CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
- K053291 — FERRITIN CALIBRATOR SET, CATALOG NO. 8203
- K060371 — THE EMIT 2000 TACROLIMUS CALIBRATORS
- K053576 — DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
- K053330 — ARCHITECT B12 CALIBRATORS
- K052148 — TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
- K052982 — ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
- K052193 — ISE COMPENSATOR
- K052002 — IRON STANDARD
- K051012 — PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
- K050231 — ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
- K043378 — DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
- K042838 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II
- K042406 — OLYMPUS LACTATE, OSR6193
- K043095 — ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
- K042521 — VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
- K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
- K042651 — FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K042490 — ELECSYS FOLATE II CALSET II
- K033860 — AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
- K040692 — OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023
- K040226 — WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
- K040471 — OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024
- K033060 — CALIBRATING MATERIAL, CALIBRATING STANDARDS
- K033786 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
- K033643 — CO2 CALIBRATOR/DILUENT
- K032458 — ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR
- K032285 — OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
- K031924 — VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1
- K031159 — CALIBRATING MATERIAL, CALIBRATING STANDARDS
- K031299 — ELECSYS LH CALSET II
Data sourced from openFDA. This site is unofficial and independent of the FDA.