| i-STAT hs-TnI cartridge with the i-STAT Alinity System (K253051) | Abbott Point of Care, Inc. | 2026-06-11 |
| VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393) | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| Access hsTnI (K243483) | Beckman Coulter, Inc. | 2025-08-01 |
| Access hsTnI (K242870) | Beckman Coulter, Inc. | 2025-06-16 |
| i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984) | Abbott Point of Care, Inc. | 2025-01-03 |
| Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 |
| PATHFAST®hs-cTnI-II (K231974) | Phc Corporation | 2024-03-20 |
| Access hsTnI (K222881) | Beckman Coulter, Inc. | 2023-12-18 |
| Access hsTnI (K230648) | Beckman Coulter, Inc. | 2023-12-04 |
| Alinity i STAT High Sensitivity Troponin-I (K230994) | Abbott Laboratories Diagnostics Division | 2023-05-04 |
| Alinity i STAT High Sensitivity Troponin-I (K202525) | Abbott Laboratories Diagnostics Division | 2022-05-19 |
| Elecsys Troponin T Gen 5 (K201441) | Roche Diagnostics | 2021-09-21 |
| ARCHITECT STAT High Sensitivity Troponin-I (K191595) | Abbott Laboratories Diagnostics Division | 2019-09-13 |
| Dimension EXL High-Sensitivity Troponin I (TNIH) Assay (K190675) | Siemens Healthcare Diagnostics, Inc. | 2019-05-17 |
| Dimension Vista High-Sensitivity Troponin I (TNIH) Assay (K182225) | Siemens Healthcare Diagnostics, Inc. | 2019-03-04 |
| Atellica IM High-Sensitivity Troponin I (TNIH) (K171566) | Siemens Healthcare Diagnostics, Inc. | 2018-07-19 |
| ADVIA Centaur High-Sensitivity Troponin I (TNIH) (K171274) | Siemens Healthcare Diagnostics, Inc. | 2018-07-12 |
| Access hsTnl (K172787) | Beckman Coulter, Inc. | 2018-06-14 |
| Access hs Tnl (K172783) | Beckman Coulter, Inc. | 2018-06-12 |
| Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (K162895) | Roche Diagnostics | 2017-01-18 |
| ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (K121790) | Beckman Coulter, Inc. | 2013-09-25 |
| ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM (K121214) | Beckman Coulter, Inc. | 2013-06-14 |
| PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 (K100130) | Mitsubishi Chemical Medience CO | 2011-05-16 |
| NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN (K102441) | Nano-Ditech Corporation | 2010-10-20 |
| NANO-CHECK AMI CTNI CARDIAC MARKER TEST (K102131) | Nano-Ditech Corporation | 2010-10-20 |
| ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS (K082699) | Roche Diagnostics | 2009-08-19 |
| DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 (K081643) | Siemens Healthcare Diagnostics | 2008-07-03 |
| VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 (K063243) | bioMerieux, Inc. | 2007-12-14 |
| ARCHITECT STAT TROPONIN-1; MYOGLOBIN (K070640) | Fisher Diagnostics | 2007-09-13 |
| DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE (K063756) | Dade Behring, Inc. | 2007-03-19 |
| VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 (K062838) | Ortho-Clinical Diagnostics | 2006-12-19 |
| ABBOTT AXSYM TROPONIN-I ADV (K060875) | Abbott Laboratories | 2006-06-14 |
| DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT (K053577) | Dade Behring, Inc. | 2006-04-14 |
| NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN (K050975) | Nano-Ditech Co. | 2006-03-02 |
| TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM (K053020) | Bayer Healthcare, LLC | 2005-12-30 |
| TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM (K052503) | Bayer Healthcare, LLC | 2005-12-14 |
| CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN (K051925) | Access Bio Incorporate | 2005-11-29 |
| VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT (K050644) | Vancouver Biotech , Ltd. | 2005-08-17 |
| ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) (K051752) | Roche Diagnostics | 2005-07-11 |
| BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 (K041619) | Biocheck, Inc. | 2004-12-17 |
| INSTANT-VIEW TROPONIN I TEST (K042227) | Alfa Scientific Designs, Inc. | 2004-11-19 |
| ABBOTT AXSYM TROPONIN-I ADV (K041811) | Abbott Laboratories | 2004-09-10 |
| ARCHITECT STAT TROPONIN-I IMMUNOASSAY (K041192) | Fisher Diagnostics | 2004-08-12 |
| RAMP TROPONIN I ASSAY (K033745) | Response Biomedical Corp. | 2004-05-17 |
| ELECSYS TROPONIN T STAT TEST (K040733) | Roche Diagnostics Corp. | 2004-05-17 |
| STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI (K033487) | Dade Behring, Inc. | 2003-12-24 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS (K031031) | Ortho-Clinical Diagnostics, Inc. | 2003-09-29 |
| I-STAT CARDIAC TROPONIN (CTNI) TEST (K031739) | I-Stat Corporation | 2003-09-02 |
| VIDAS TROPONIN I (TNI), MODEL 30 445 (K030950) | bioMerieux, Inc. | 2003-06-16 |
| VBL SERUM TROPONIN I TEST, MODEL 1001 (K023505) | Vancouver Biotech , Ltd. | 2003-03-31 |
| SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (K030057) | Spectral Diagnostics, Inc. | 2003-03-19 |
| MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS (K024193) | Ortho-Clinical Diagnostics | 2003-02-21 |
| LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST (K022946) | Princeton BioMeditech Corp. | 2002-10-08 |
| ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 (K021814) | Beckman Coulter, Inc. | 2002-09-27 |
| SPECTRAL'S 2 IN 1 (TNI-MYO) (K020950) | Spectral Diagnostics, Inc. | 2002-05-24 |
| MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS (K020662) | Ortho-Clinical Diagnostics | 2002-04-12 |
| SPECTRAL'S TROPONIN I (K014105) | Spectral Diagnostics, Inc. | 2002-02-01 |
| BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT (K013062) | Biocheck, Inc. | 2002-01-08 |
| MODIFICATION TO ALPHA DX SYSTEM (K014024) | First Medical, Inc. | 2001-12-18 |
| AIA-PACK CTNI 2ND-GEN ASSAY (K012820) | Tosoh Medics, Inc. | 2001-12-14 |
| ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 (K010429) | Beckman Coulter, Inc. | 2001-06-05 |
| DIMENSION CTNI FLEX REAGENT CARTRIDGE (K010313) | Dade Behring, Inc. | 2001-04-20 |
| BAYER ADVIA IMS SYSTEM (K010201) | Bayer Corp. | 2001-03-29 |
| ALPHA DX SYSTEM (K010562) | First Medical, Inc. | 2001-03-13 |
| THE CARDIAC READER SYSTEM (K000784) | Roche Diagnostics Corp. | 2000-05-18 |
| TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) (K993353) | Bayer Corp. | 1999-12-06 |
| BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY (K993309) | Bayer Corp. | 1999-12-06 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK (K992366) | Ortho-Clinical Diagnostics, Inc. | 1999-10-08 |
| CARDIOQUANT TROPONIN I TEST (K992127) | Spectral Diagnostics, Inc. | 1999-10-04 |
| OPUS TROPONIN I (CTN) TEST MODULES (K991177) | Dade Behring, Inc. | 1999-07-01 |
| IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 (K991795) | Diagnostic Products Corp. | 1999-06-09 |
| AIA-PACK TROPONIN I ASSAY (K984359) | Tosoh Medics, Inc. | 1998-12-23 |
| STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK (K984093) | Dade Behring, Inc. | 1998-12-14 |
| ELECSYS TROPONIN T STAT TEST (K984105) | Boehringer Mannheim Corp. | 1998-12-08 |
| IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 (K983972) | Diagnostic Products Corp. | 1998-12-07 |
| CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST (K981882) | Princeton BioMeditech Corp. | 1998-07-06 |
| STRATUS CS CARDIAC TROPONIN I TESTPAK (K981098) | Dade Behring, Inc. | 1998-04-27 |
| CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) (K980528) | Chiron Diagnostics Corp. | 1998-03-03 |
| 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 (K974839) | First Medical, Inc. | 1998-02-04 |
| ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K974818) | Radiometer America, Inc. | 1998-01-16 |
| TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K973616) | Bayer Corp. | 1997-12-05 |
| ABBOTT AXSYM TROPONIN-I (K974103) | Abbott Laboratories | 1997-11-25 |
| ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K974075) | Beckman Instruments, Inc. | 1997-11-10 |
| TROPONIN (TROP) METHOD (K973650) | Dade Chemistry Systems, Inc. | 1997-10-20 |
| TARGET CARDIAC TROPONIN I TEST (K972094) | Texas Immunology, Inc. | 1997-07-23 |
| CARDIAC T TROPONIN T RAPID ASSAY (K964372) | Boehringer Mannheim Corp. | 1997-02-10 |
| TROPONIN-I TEST SYSTEM (K964862) | Dade Intl., Inc. | 1997-02-10 |
| ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329 (K963934) | Bio-Rad Laboratories, Inc. | 1996-12-16 |
| CARDIAC STATUS TROPONIN I (K963513) | Princeton BioMeditech Corp. | 1996-11-07 |
| ELECSYS TROPONIN T (K961500) | Boehringer Mannheim Corp. | 1996-06-11 |
| BOEHRINGER MANNHEIM CARDIAC T TROPNIN T (K955868) | Boehringer Mannheim Corp. | 1996-02-14 |
| OPUS TROPONIN I (K955284) | Behring Diagnostics, Inc. | 1996-01-25 |
| BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY (K952478) | Boehringer Mannheim Corp. | 1995-11-09 |
| STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS (K951890) | Dade Intl., Inc. | 1995-07-13 |
| CARDIAC T ELISA TROPONIN-T (K924392) | Boehringer Mannheim Corp. | 1994-04-26 |