FDA 510(k) Applications for Medical Device Product Code "JJT"
(Enzyme Controls (Assayed And Unassayed))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K090940 | ASTORIA-PACIFIC,INC. | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | 12/14/2009 |
| K030102 | BAYER HEALTHCARE, LLC | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 | 01/24/2003 |
| K960275 | BEHRING DIAGNOSTICS, INC. | OPUS CK-MB & TOTAL CK CONTROLS | 04/25/1996 |
| K961828 | BIO-RAD | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) | 06/11/1996 |
| K980556 | BIO-RAD | LIQUICHEK CARDIAC MARKERS CONTROL LT | 02/25/1998 |
| K021498 | BIO-RAD | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL | 05/24/2002 |
| K012656 | BIO-RAD | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 | 09/06/2001 |
| K974461 | BIOSITE INCORPORATED | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL | 12/10/1997 |
| K960246 | CIBA CORNING DIAGNOSTICS CORP. | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | 04/23/1996 |
| K030768 | CLINIQA CORPORATION | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL | 03/21/2003 |
| K973974 | DADE INTL., INC. | DADE TRU-LIQUID CARDIAC CONTROL | 11/06/1997 |
| K971777 | INSTRUMENTATION LABORATORY CO. | QUANTEX ASO-CRP-RF CONTROL | 05/27/1997 |
| K984437 | INSTRUMENTATION LABORATORY CO. | QUANTEX ASO-CRP-RP CONTROL II | 02/02/1999 |
| K984277 | MEDICAL ANALYSIS SYSTEMS, INC. | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | 12/09/1998 |
| K992430 | MEDICAL ANALYSIS SYSTEMS, INC. | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | 08/30/1999 |
| K970856 | MEDICAL ANALYSIS SYSTEMS, INC. | CARDIOISOZYME, CK/LD ISOENZYME CONTROL | 04/08/1997 |
| K972976 | MORE DIAGNOSTICS | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | 08/29/1997 |
| K982845 | MORE DIAGNOSTICS | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 | 08/21/1998 |
| K993723 | QUANTIMETRIX CORP. | CARDIASURE CARDIAC MARKERS CONTROL | 11/23/1999 |
| K062751 | QUANTIMETRIX CORP. | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | 10/03/2006 |
| K993715 | SERACARE TECHNOLOGY | QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 | 11/16/1999 |
| K965168 | SPECIALIZED ASSAYS, INC. | STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) | 02/04/1997 |
| K965169 | SPECIALIZED ASSAYS, INC. | STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) | 02/06/1997 |
| K965166 | SPECIALIZED ASSAYS, INC. | STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) | 02/04/1997 |
| K972408 | SPECTRAL DIAGNOSTICS, INC. | CARDIAC STATUS CONTROLS | 07/25/1997 |
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