Product code JJT— Clinical Chemistry
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
- Classification name
- Enzyme Controls (Assayed And Unassayed)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Total cleared
- 97
- First cleared
- Most recent
Market context for product code JJT
FDA has cleared devices under product code JJT between 1977 and 2009, filed by 54 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- 2009
- 2006
- 2003
- 2002
- 2001
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
Top applicants under product code JJT
Recent clearances under product code JJT
- K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
- K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
- K030768 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
- K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
- K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
- K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
- K993723 — CARDIASURE CARDIAC MARKERS CONTROL
- K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
- K992430 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
- K984437 — QUANTEX ASO-CRP-RP CONTROL II
- K984277 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
- K982845 — CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
- K980556 — LIQUICHEK CARDIAC MARKERS CONTROL LT
- K974461 — TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL
- K973974 — DADE TRU-LIQUID CARDIAC CONTROL
- K972976 — CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
- K972408 — CARDIAC STATUS CONTROLS
- K971777 — QUANTEX ASO-CRP-RF CONTROL
- K970856 — CARDIOISOZYME, CK/LD ISOENZYME CONTROL
- K965169 — STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
- K965166 — STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
- K965168 — STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
- K961828 — LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
- K960275 — OPUS CK-MB & TOTAL CK CONTROLS
- K960246 — LIQUID CARDIAC MARKER 1,2,3 ASSAYED
- K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
- K951293 — QUANTITATE ENZYME VERIFIER SET
- K950801 — CARDIO REP LD CONTROL - CAT NO. 3325
- K946145 — CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL
- K946146 — CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
- K944923 — CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
- K944246 — CARDIOCHEX CKMB MASS MEASUREMENT CONTROL
- K944247 — CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL
- K944243 — CARDIOCHEX
- K943684 — HICHEM ENZYME VERIFIER KIT
- K932442 — CARDIO REP RECOMBINANT CK ABNORMAL CONTROL
- K930889 — ROCHE CARDIOTROL-CK
- K930873 — CKMB ISOENZYME CONTROL-LEVEL 1,2.3
- K930875 — CKMB CONTROL - LEVEL 1,2,3
- K925151 — LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
- K905623 — CK-MB IMMUNOASSAY CONTROL
- K903430 — LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2
- K902321 — HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
- K896465 — CLP CK/LD ISOENZYME/IMMUNO CONTROL
- K894554 — CLP CK/LD ISOENZYME CONTROL
- K894207 — CK-MB/LD-1 CONTROL SYSTEM
- K883395 — ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
- K882795 — DADE(R) CK-MB IMMUNOASSAY CONTROL
- K880701 — QUANTIMETRIX SERUM ENZYME CONTROL
- K880266 — MULTI-ENZYME LINEARITY SOLUTION
- K874302 — QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
- K874141 — TITAN GEL REP CPK/LDH ISOENZYME CONTROL
- K872646 — VIRON(TM)
- K870737 — U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
- K870738 — U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL
- K861506 — DOCUMENT ENZYME LINEARITY TEST SETS
- K861512 — EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
- K861329 — ISOTRAK AMYLASE ISOENZYME CONTROL SET
- K860764 — EMDS ENZYME VERIFIER, LEVELS I & II
- K855006 — CANTROL CK/MB CONTROL
- K854973 — V-TREND OC CPK
- K853373 — DELTA TROL I & II
- K850907 — CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
- K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN)
- K850213 — ISOCONTROL SERUM CK-MB
- K850211 — ISOCONTROL SERUM LD-
- K843265 — ID ZINE LD ISOENZYME CONTROL ABNORM
- K843266 — ID ZONE NORMAL LD ISOENZYME CONTROL
- K840793 — CK/MB IMMUNO-ISOENZYME CONTROL SERUM
- K822984 — ID-ZONE LD ISOENZYME CONTROL
- K822646 — QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM
- K821981 — TITAN GEL CPK/LDH ISOENZYME CONTROL
- K821183 — TARGET ISOCHECK CONTROL SERUM
- K820360 — AALTO LDH ISOENZYME CONTROL SERUM
- K812671 — EMBRITROL CK-MB CONTROLS
- K810870 — GEMENI CK-MB ISOENZYME ABNORMAL SERUM
- K810725 — QUALITROL #65057
- K803305 — DUPONT 'ACA' CREATINE KINASE VERIFIERS
- K800604 — CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
- K791723 — QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
- K791299 — CPK ISOENZYME CONTROL
- K791300 — LDH ISOENZYME CONTROL
- K790985 — P.A.P. RIA CONTROL SERUM PACK
- K781100 — DELTA TEST AMYLASE/LIPASE CONTS. I,II
- K780801 — ISOZYME - ID CPK MARKER
- K780554 — CLIN. CHEM. CONTROL SERUM-QUANTITATE
- K780204 — CHEMISTRY CONTROL & REFERENCE SERUMS
- K780147 — ISOENZYME SERUM CONTROL
- K771800 — ACA GLUTAMYL TRANSFERASE
- K771740 — CARDIOZYME CK-CONTROL LEVEL 1
- K771436 — SERONORM
- K771438 — AUTONORM
- K771439 — PATHONORM H & L
- K770971 — CARDIOZYME CK-CONTROL ABNORMAL
- K770973 — CARDIOZYME CK CONTROL NORMAL
- K770555 — CPK ISOENZYME CONTROL
- K770049 — LDH ISOTROL T
Data sourced from openFDA. This site is unofficial and independent of the FDA.