Panels › Clinical Chemistry › Product code MMI · Class 2
Immunoassay Method, Troponin Subunit
Regulation 862.1215
1510(k)s in 12 months (95 all time)
0recalls in 12 months (56 all time)
54recalls that name a 510(k)
Top companies in MMI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 19, 2003 | K030057 | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST Spectral Diagnostics, Inc., CA | MMI |
| Feb 21, 2003 | K024193 | MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS Ortho-Clinical Diagnostics | MMI |
| Oct 8, 2002 | K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST Princeton BioMeditech Corp. | MMI |
| Sep 27, 2002 | K021814 | ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 Beckman Coulter, Inc. | MMI |
| May 24, 2002 | K020950 | SPECTRAL'S 2 IN 1 (TNI-MYO) Spectral Diagnostics, Inc., CA | MMI |
| Apr 12, 2002 | K020662 | MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS Ortho-Clinical Diagnostics | MMI |
| Feb 1, 2002 | K014105 | SPECTRAL'S TROPONIN I Spectral Diagnostics, Inc., CA | MMI |
| Jan 8, 2002 | K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT Biocheck, Inc. | MMI |
| Dec 18, 2001 | K014024 | MODIFICATION TO ALPHA DX SYSTEM First Medical, Inc. | MMI |
| Dec 14, 2001 | K012820 | AIA-PACK CTNI 2ND-GEN ASSAY Tosoh Medics, Inc. | MMI |
| Jun 5, 2001 | K010429 | ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 Beckman Coulter, Inc. | MMI |
| Apr 20, 2001 | K010313 | DIMENSION CTNI FLEX REAGENT CARTRIDGE Dade Behring, Inc. | MMI |
| Mar 29, 2001 | K010201 | BAYER ADVIA IMS SYSTEM Bayer Corp. | MMI |
| Mar 13, 2001 | K010562 | ALPHA DX SYSTEM First Medical, Inc. | MMI |
| May 18, 2000 | K000784 | THE CARDIAC READER SYSTEM Roche Diagnostics Corp. | MMI |
| Dec 6, 1999 | K993353 | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | MMI |
| Dec 6, 1999 | K993309 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY Bayer Corp. | MMI |
| Oct 8, 1999 | K992366 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK Ortho-Clinical Diagnostics, Inc. | MMI |
| Oct 4, 1999 | K992127 | CARDIOQUANT TROPONIN I TEST Spectral Diagnostics, Inc. | MMI |
| Jul 1, 1999 | K991177 | OPUS TROPONIN I (CTN) TEST MODULES Dade Behring, Inc. | MMI |
| Jun 9, 1999 | K991795 | IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 Diagnostic Products Corp. | MMI |
| Dec 23, 1998 | K984359 | AIA-PACK TROPONIN I ASSAY Tosoh Medics, Inc. | MMI |
| Dec 14, 1998 | K984093 | STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK Dade Behring, Inc. | MMI |
| Dec 8, 1998 | K984105 | ELECSYS TROPONIN T STAT TEST Boehringer Mannheim Corp. | MMI |
| Dec 7, 1998 | K983972 | IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 Diagnostic Products Corp. | MMI |
| Jul 6, 1998 | K981882 | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST Princeton BioMeditech Corp. | MMI |
| Apr 27, 1998 | K981098 | STRATUS CS CARDIAC TROPONIN I TESTPAK Dade Behring, Inc. | MMI |
| Mar 3, 1998 | K980528 | CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) Chiron Diagnostics Corp. | MMI |
| Feb 4, 1998 | K974839 | ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT First Medical, Inc. | MMI |
| Jan 16, 1998 | K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc. | MMI |
| Dec 5, 1997 | K973616 | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. | MMI |
| Nov 25, 1997 | K974103 | ABBOTT AXSYM TROPONIN-I Abbott Laboratories | MMI |
| Nov 10, 1997 | K974075 | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | MMI |
| Oct 20, 1997 | K973650 | TROPONIN (TROP) METHOD Dade Chemistry Systems, Inc. | MMI |
| Jul 23, 1997 | K972094 | TARGET CARDIAC TROPONIN I TEST Texas Immunology, Inc. | MMI |
| Feb 10, 1997 | K964862 | TROPONIN-I TEST SYSTEM Dade Intl., Inc. | MMI |
| Feb 10, 1997 | K964372 | CARDIAC T TROPONIN T RAPID ASSAY Boehringer Mannheim Corp. | MMI |
| Dec 16, 1996 | K963934 | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 Bio-Rad Laboratories, Inc. | MMI |
| Nov 7, 1996 | K963513 | CARDIAC STATUS TROPONIN I Princeton BioMeditech Corp. | MMI |
| Jun 11, 1996 | K961500 | ELECSYS TROPONIN T Boehringer Mannheim Corp. | MMI |
| Feb 14, 1996 | K955868 | BOEHRINGER MANNHEIM CARDIAC T TROPNIN T Boehringer Mannheim Corp. | MMI |
| Jan 25, 1996 | K955284 | OPUS TROPONIN I Behring Diagnostics, Inc. | MMI |
| Nov 9, 1995 | K952478 | BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY Boehringer Mannheim Corp. | MMI |
| Jul 13, 1995 | K951890 | STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS Dade Intl., Inc. | MMI |
| Apr 26, 1994 | K924392 | CARDIAC T ELISA TROPONIN-T Boehringer Mannheim Corp. | MMI |
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