FDA 510(k) Applications Submitted by Roche Diagnostics

FDA 510(k) Number Submission Date Device Name Applicant
K160729 03/16/2016 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 Roche Diagnostics
K160915 04/01/2016 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker ROCHE DIAGNOSTICS
K150955 04/09/2015 Elecsys Progesterone III Cal Check 5 ROCHE DIAGNOSTICS
K162173 08/03/2016 Elecsys CYFRA 21-1 CalCheck 5 Roche Diagnostics
K171605 06/01/2017 Elecsys CA 15-3 II Roche Diagnostics
K181492 06/06/2018 Elecsys CA 15-3 II Roche Diagnostics
K101299 05/10/2010 ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics
K110726 03/16/2011 ROCHE ACETAMINOPHEN ASSAY Roche Diagnostics
K160910 04/01/2016 Elecsys Syphilis ROCHE DIAGNOSTICS
K162606 09/19/2016 Elecsys TSH assay, cobas e 801 Immunoassay analyzer ROCHE DIAGNOSTICS
K153607 12/17/2015 ROMA Calculation Tool Using Elecsys Assays ROCHE DIAGNOSTICS
K163569 12/19/2016 Elecsys CMV IgM Roche Diagnostics
K180693 03/16/2018 CoaguChek XS Pro System Roche Diagnostics
K180684 03/15/2018 CoaguChek XS Plus System Roche Diagnostics
K071211 05/01/2007 COBAS C 111 ANALYZER Roche Diagnostics
K071239 05/03/2007 TOTAL PROTEIN URINE/CSF GEN.3 Roche Diagnostics
K052193 08/11/2005 ISE COMPENSATOR Roche Diagnostics
K140373 02/14/2014 ISE INDIRECT NA, K, C1 FOR GEN 2 Roche Diagnostics
K123726 12/04/2012 COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 Roche Diagnostics
K050423 02/18/2005 OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) Roche Diagnostics
K170678 03/06/2017 Beta-CrossLaps CalCheck 5 Roche Diagnostics
K131244 05/01/2013 ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET Roche Diagnostics
K122242 07/27/2012 ELECSYS CA 15-3 II CALCHECK 5 Roche Diagnostics
K153301 11/13/2015 Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II ROCHE DIAGNOSTICS
DEN150057 12/09/2015 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 ROCHE DIAGNOSTICS
K090541 03/02/2009 ELECSYS PRECICONTROL UNIVERSAL Roche Diagnostics
K083260 11/05/2008 ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN Roche Diagnostics
K093582 11/19/2009 ELECSYS CK-MB CALCHECK 5 Roche Diagnostics
K140112 01/15/2014 CA 125 II CALSET II Roche Diagnostics
K140534 03/04/2014 ELECSYS PRECICONTROL TS Roche Diagnostics
K112624 09/08/2011 ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 Roche Diagnostics
K082699 09/15/2008 ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS Roche Diagnostics
K162895 10/17/2016 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 Roche Diagnostics
K131605 06/03/2013 ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY Roche Diagnostics
K112104 07/22/2011 ELECSYS N-MID OSTEOCALCIN CALCHECK 5 Roche Diagnostics
K101856 07/01/2010 ELECSYS CEA CALCHECK 5 Roche Diagnostics
K060978 04/10/2006 COAGUCHEK XS SYSTEM Roche Diagnostics
K081193 04/28/2008 COBAS INTEGRA 400/800 BILIRUBIN TOTAL Roche Diagnostics
K051376 05/26/2005 ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE Roche Diagnostics
K093460 11/06/2009 COAGUCHEK XS PRO SYSTEM Roche Diagnostics
K093555 11/17/2009 COBAS U411 TEST SYSTEM Roche Diagnostics
K170960 03/31/2017 CoaguChek Vantus System Roche Diagnostics
K120625 03/01/2012 ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV Roche Diagnostics
K121279 04/30/2012 ELECSYS LH CALCHECK 5 Roche Diagnostics
K121895 06/29/2012 ELECSYS HSV-2 IGG IMMUNOASSAY Roche Diagnostics
K100538 02/25/2010 TINA-QUANT FERRITIN GEN. 4 Roche Diagnostics
K101203 04/29/2010 TINA-QUANT ALBUMIN GEN 2 Roche Diagnostics
K091741 06/16/2009 TINA-QUANT CERULOPLASMIN Roche Diagnostics
K092603 08/25/2009 COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY Roche Diagnostics
K103716 12/21/2010 ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET Roche Diagnostics
K070788 03/22/2007 ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics
K072437 08/23/2007 ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET Roche Diagnostics
K061970 07/12/2006 ELECSYS IGE II IMMUNOASSAY Roche Diagnostics
K140404 02/18/2014 ELECSYS CK-MB STAT IMMUNOASSAY Roche Diagnostics
K141426 05/30/2014 ELECSYS FOLATE III Roche Diagnostics
K151786 07/01/2015 Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet Roche Diagnostics
K142021 07/25/2014 Elecsys Estradiol III CalSet Roche Diagnostics
K142127 08/04/2014 ELECSYS ESTRADIOL III CALCHECK 5 Roche Diagnostics
K152227 08/07/2015 Elecsys Cortisol II, Cortisol II CalSet ROCHE DIAGNOSTICS
K132571 08/15/2013 ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY Roche Diagnostics
K132828 09/09/2013 ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics
K162678 09/26/2016 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl ROCHE DIAGNOSTICS
K133284 10/25/2013 ELECSYS CK-MB CALCHECK 5 Roche Diagnostics
K143284 11/17/2014 Elecsys Estradiol III Calcheck ROCHE DIAGNOSTICS
K143342 11/21/2014 Elecsys T-Uptake Calset Roche Diagnostics
K100810 03/22/2010 ELECSYS C-PEPTIDE CALCHECK 5 Roche Diagnostics
K102044 07/21/2010 ELECSYS DIGOXIN CALCHECK 5 Roche Diagnostics
K090311 02/06/2009 ELECSYS RUBELLA IGG CALCHECK Roche Diagnostics
K111349 05/13/2011 ELECSYS SHBG CALCHECK 5 Roche Diagnostics
K111552 06/03/2011 ELECSYS T3 CALCHECK 5 Roche Diagnostics
K092169 07/21/2009 ELECSYS PROBNP II CALCHECK 5 Roche Diagnostics
K102086 07/26/2010 ELECSYS CA 125 II CALCHECK 5 Roche Diagnostics
K092585 08/24/2009 ELECSYS RUBELLA IGGA CALCHECK 5 Roche Diagnostics
K102814 09/28/2010 ELECYSYS SHBG Roche Diagnostics
K103162 10/27/2010 ELECSYS PTH CALCHECK 5 Roche Diagnostics
K083655 12/10/2008 ELECSYS TOXO IGG CALCHECK Roche Diagnostics
K093955 12/23/2009 ANTI-HAV IGM Roche Diagnostics
K103221 11/01/2010 ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 Roche Diagnostics
K103402 11/19/2010 ELECSYS DHEA-S CALCHECK 5 Roche Diagnostics
K094031 12/30/2009 ELECSYS FOLATE III CALCHECK 5 Roche Diagnostics
K110613 03/03/2011 ELECSYS PROLACTIN II CALCHECK 5 Roche Diagnostics
K112113 07/25/2011 ELECSYS MYOGLOBIN CALCHECK 5 Roche Diagnostics
K093836 12/15/2009 ELECSYS TSH CALCHECK 5 Roche Diagnostics
K060373 02/13/2006 COBAS 6000 SERIES SYSTEM Roche Diagnostics
K063520 11/21/2006 ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS Roche Diagnostics
K141143 05/02/2014 COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET Roche Diagnostics
K132418 08/02/2013 COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 Roche Diagnostics
K141867 07/10/2014 ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics
K113137 10/24/2011 GLUCOSE TEST SYSTEM Roche Diagnostics
K162840 10/11/2016 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 Roche Diagnostics
K131544 05/29/2013 COBAS C BILIRUBIN TOTAL GEN.3 Roche Diagnostics
K122722 09/05/2012 COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 Roche Diagnostics
K113521 11/29/2011 CALCIUM GEN. 2 Roche Diagnostics
K170938 03/30/2017 CalSet IGF-1 Roche Diagnostics
K113614 12/06/2011 ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics
K113546 12/01/2011 ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 Roche Diagnostics
K093867 01/05/2010 ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A Roche Diagnostics
K093989 12/24/2009 ORAL FLUID PHENCYCLIDINE Roche Diagnostics
K090939 04/03/2009 ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 Roche Diagnostics
K110446 02/16/2011 ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID Roche Diagnostics
K101160 04/26/2010 ROCHE ORAL FLUID COCAINE Roche Diagnostics
K093884 12/18/2009 ROCHE FLUDI METHAMPHETAMINE Roche Diagnostics
K121679 06/07/2012 ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics
K133741 12/09/2013 ACCU-CHEK Performa Blood Glucose Monitoring System Roche Diagnostics
K162526 09/09/2016 Creatine Kinase-MB ROCHE DIAGNOSTICS
K102016 07/19/2010 PRECICONTROL CLINCHEM MULTI 1 AND 2 Roche Diagnostics
K152526 09/03/2015 Elecsys Progesterone III CalSet ROCHE DIAGNOSTICS
K052982 10/24/2005 ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET Roche Diagnostics
K053059 10/31/2005 ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK Roche Diagnostics
K100594 03/02/2010 ELECSYS TROPONIN I CALCHECK 5 Roche Diagnostics
K111188 04/27/2011 COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B Roche Diagnostics
K111506 06/01/2011 ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics
K092168 07/21/2009 ELECSYS HCG+B CALCHECK 5 Roche Diagnostics
K102157 07/30/2010 ELECSYS PRECICONTROL MULTIMARKER Roche Diagnostics
K092320 08/04/2009 ELECSYS PRECICONTROL THYROAB Roche Diagnostics
K142133 08/04/2014 ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM Roche Diagnostics
K102267 08/09/2010 ELECSYS FERRITIN CALCHECK 5 Roche Diagnostics
K102269 08/09/2010 ELECSYS IGE CALCHECK 5 Roche Diagnostics
K103171 10/27/2010 ELECSYS ANTI-TPO CALSET Roche Diagnostics
K111353 05/16/2011 ACCU-CHECK COMBO SYSTEM Roche Diagnostics
K081389 05/19/2008 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics
K082595 09/08/2008 MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE Roche Diagnostics
K080643 03/06/2008 ELECSYS ANTI-TSHR CALCHECK Roche Diagnostics
K081338 05/13/2008 ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP Roche Diagnostics
K110313 02/02/2011 TINA-QUANT HBA1C GEN.2 Roche Diagnostics
DEN130002 03/25/2013 TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics
K121291 04/30/2012 TINA-QUANT HBA1C GEN. 2 TEST SYSTEM ROCHE DIAGNOSTICS
K101456 05/26/2010 ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM Roche Diagnostics
K103099 10/20/2010 PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH Roche Diagnostics
K133330 11/01/2013 C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN Roche Diagnostics
K123965 12/26/2012 COBAS INTEGRA BILIRUBIN DIRECT GEN.2 Roche Diagnostics
K071041 04/12/2007 COAGUCHEK XS PLUS SYSTEM Roche Diagnostics
K092322 08/04/2009 ELECSYS RUBELLA IGM IMMUNOASSAY Roche Diagnostics
K050026 01/06/2005 PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC Roche Diagnostics
K051752 06/29/2005 ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) Roche Diagnostics
K052101 08/03/2005 C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C Roche Diagnostics
K173927 12/26/2017 Elecsys BRAHMS PCT Roche Diagnostics


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