Panels › Clinical Chemistry › Product code JJT · Class 1
Enzyme Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (97 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JJT
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Instruments, Inc. | 7 | 0 |
| Bio-Rad | 6 | 0 |
| Cala Diagnostics | 6 | 0 |
| Dade, Baxter Travenol Diagnostics, Inc. | 4 | 0 |
| Helena Laboratories | 4 | 0 |
| Clinical Controls, Inc. | 3 | 0 |
| Medical Analysis Systems, Inc. | 3 | 0 |
| Nyegaard & Co. A/S | 3 | 0 |
| Quantimetrix Corp. | 3 | 0 |
| Specialized Assays, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2009 | K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED Astoria-Pacific, Inc. | JJT |
| Oct 3, 2006 | K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER Quantimetrix Corp. | JJT |
| Mar 21, 2003 | K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL Cliniqa Corporation | JJT |
| Jan 24, 2003 | K030102 | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 Bayer Healthcare, LLC | JJT |
| May 24, 2002 | K021498 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL Bio-Rad | JJT |
| Sep 6, 2001 | K012656 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 Bio-Rad | JJT |
| Nov 23, 1999 | K993723 | CARDIASURE CARDIAC MARKERS CONTROL Quantimetrix Corp. | JJT |
| Nov 16, 1999 | K993715 | QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 Seracare Technology | JJT |
| Aug 30, 1999 | K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. | JJT |
| Feb 2, 1999 | K984437 | QUANTEX ASO-CRP-RP CONTROL II Instrumentation Laboratory CO | JJT |
| Dec 9, 1998 | K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. | JJT |
| Aug 21, 1998 | K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 More Diagnostics | JJT |
| Feb 25, 1998 | K980556 | LIQUICHEK CARDIAC MARKERS CONTROL LT Bio-Rad | JJT |
| Dec 10, 1997 | K974461 | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL Biosite Incorporated | JJT |
| Nov 6, 1997 | K973974 | DADE TRU-LIQUID CARDIAC CONTROL Dade Intl., Inc. | JJT |
| Aug 29, 1997 | K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL More Diagnostics | JJT |
| Jul 25, 1997 | K972408 | CARDIAC STATUS CONTROLS Spectral Diagnostics, Inc., CA | JJT |
| May 27, 1997 | K971777 | QUANTEX ASO-CRP-RF CONTROL Instrumentation Laboratory CO | JJT |
| Apr 8, 1997 | K970856 | CARDIOISOZYME, CK/LD ISOENZYME CONTROL Medical Analysis Systems, Inc. | JJT |
| Feb 6, 1997 | K965169 | STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) Specialized Assays, Inc. | JJT |
| Feb 4, 1997 | K965168 | STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) Specialized Assays, Inc. | JJT |
| Feb 4, 1997 | K965166 | STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) Specialized Assays, Inc. | JJT |
| Jun 11, 1996 | K961828 | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) Bio-Rad | JJT |
| Apr 25, 1996 | K960275 | OPUS CK-MB & TOTAL CK CONTROLS Behring Diagnostics, Inc. | JJT |
| Apr 23, 1996 | K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED Ciba Corning Diagnostics Corp. | JJT |
| Sep 21, 1995 | K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE Isolab, Inc. | JJT |
| Apr 20, 1995 | K951293 | QUANTITATE ENZYME VERIFIER SET Beckman Instruments, Inc. | JJT |
| Mar 30, 1995 | K950801 | CARDIO REP LD CONTROL - CAT NO. 3325 Helena Laboratories | JJT |
| Jan 24, 1995 | K946146 | CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION Clinical Controls, Inc. | JJT |
| Jan 24, 1995 | K946145 | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL Clinical Controls, Inc. | JJT |
| Nov 4, 1994 | K944923 | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, Clinical Controls, Inc. | JJT |
| Oct 31, 1994 | K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL Cala Diagnostics | JJT |
| Oct 31, 1994 | K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL Cala Diagnostics | JJT |
| Oct 27, 1994 | K944243 | CARDIOCHEX Cala Diagnostics | JJT |
| Oct 4, 1994 | K943684 | HICHEM ENZYME VERIFIER KIT Hi Chem, Inc. | JJT |
| Oct 28, 1993 | K932442 | CARDIO REP RECOMBINANT CK ABNORMAL CONTROL Helena Laboratories | JJT |
| Jul 6, 1993 | K930889 | ROCHE CARDIOTROL-CK Roche Diagnostic Systems, Inc. | JJT |
| Apr 13, 1993 | K930875 | CKMB CONTROL - LEVEL 1,2,3 Cala Diagnostics | JJT |
| Apr 13, 1993 | K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 Cala Diagnostics | JJT |
| Dec 17, 1992 | K925151 | LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 Bio-Rad | JJT |
| Feb 22, 1991 | K905623 | CK-MB IMMUNOASSAY CONTROL Seradyn, Inc. | JJT |
| Aug 23, 1990 | K903430 | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 Bio-Rad | JJT |
| Jun 28, 1990 | K902321 | HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) Hichem Diagnostics | JJT |
| Mar 1, 1990 | K896465 | CLP CK/LD ISOENZYME/IMMUNO CONTROL Creative Laboratory Products, Inc. | JJT |
| Oct 16, 1989 | K894554 | CLP CK/LD ISOENZYME CONTROL Creative Laboratory Products, Inc. | JJT |
| Aug 28, 1989 | K894207 | CK-MB/LD-1 CONTROL SYSTEM Boehringer Mannheim Corp. | JJT |
| Sep 19, 1988 | K883395 | ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY Quantimetrix Medical Industries | JJT |
| Aug 29, 1988 | K882795 | DADE(R) CK-MB IMMUNOASSAY CONTROL Baxter Healthcare Corp | JJT |
| Mar 24, 1988 | K880701 | QUANTIMETRIX SERUM ENZYME CONTROL Quantimetrix Corp. | JJT |
| Feb 18, 1988 | K880266 | MULTI-ENZYME LINEARITY SOLUTION Verichem Laboratories, Inc. | JJT |
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