| SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM (K130138) | Roche Diagnostics Corp. | 2013-03-15 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| COBAS 8000 MODULAR SERIES ANALYZER (K100853) | Roche Diagnostics Corp. | 2010-09-09 |
| ACCU-CHEK ULTRFLEX INFUSION SET (K101196) | Roche Diagnostics Corp. | 2010-08-27 |
| AMPHETAMINES II ASSAY (K093664) | Roche Diagnostics Corp. | 2010-07-28 |
| ELECSYS INSULIN CALCHECK 5 (K101075) | Roche Diagnostics Corp. | 2010-06-11 |
| ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421) | Roche Diagnostics Corp. | 2010-04-23 |
| ELECSYS TROPONIN T CALCHECK 5 (K092848) | Roche Diagnostics Corp. | 2010-03-19 |
| COAGUCHEK XS PLUS PST SYSTEM (K092940) | Roche Diagnostics Corp. | 2010-03-05 |
| ELECSYS HCG STAT CALCHECK 5 (K093700) | Roche Diagnostics Corp. | 2010-03-04 |
| ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 (K092649) | Roche Diagnostics Corp. | 2010-02-04 |
| AMPHETAMINES II (K083764) | Roche Diagnostics Corp. | 2010-02-03 |
| ELECSYS TOXO IGG CALCHECK 5 (K092888) | Roche Diagnostics Corp. | 2009-11-10 |
| ELECYS ANTI-CCP CALCHECK (K091601) | Roche Diagnostics Corp. | 2009-09-25 |
| ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS (K082340) | Roche Diagnostics Corp. | 2009-06-19 |
| C-REACTIVE PROTEIN (LATEX) (K083444) | Roche Diagnostics Corp. | 2009-03-18 |
| ELECSYS RUBELLA IGG IMMUNOASSAY (K072617) | Roche Diagnostics Corp. | 2008-12-05 |
| ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB (K080092) | Roche Diagnostics Corp. | 2008-07-28 |
| TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET (K080811) | Roche Diagnostics Corp. | 2008-06-20 |
| ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501) | Roche Diagnostics Corp. | 2008-06-09 |
| ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM (K080227) | Roche Diagnostics Corp. | 2008-05-15 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 (K080607) | Roche Diagnostics Corp. | 2008-05-12 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM (K072714) | Roche Diagnostics Corp. | 2008-04-18 |
| CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 (K080183) | Roche Diagnostics Corp. | 2008-03-25 |
| COBAS LITHIUM (K063684) | Roche Diagnostics Corp. | 2008-03-21 |
| ROCHE-CREACTIVE PROTEIN (LATEX) (K073277) | Roche Diagnostics Corp. | 2008-03-06 |
| ELECSYS PROBNP II CALCHECK (K080147) | Roche Diagnostics Corp. | 2008-02-27 |
| HANDHELD BASE UNIT (K072920) | Roche Diagnostics Corp. | 2008-01-31 |
| ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (K072638) | Roche Diagnostics Corp. | 2007-10-19 |
| ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (K071644) | Roche Diagnostics Corp. | 2007-09-12 |
| ROCHE ELECSYS PTH TEST SYSTEM (K070709) | Roche Diagnostics Corp. | 2007-07-13 |
| ACCU-CHEK PERFORMA SYSTEM (K070585) | Roche Diagnostics Corp. | 2007-05-25 |
| ACCU-CHEK SMART PIX (K062395) | Roche Diagnostics Corp. | 2007-05-09 |
| ELECSYS PTH TEST SYSTEM (K070391) | Roche Diagnostics Corp. | 2007-03-20 |
| TDM CONTROL SET, MODEL CAT# 04521536 (K070200) | Roche Diagnostics Corp. | 2007-03-19 |
| TINA-QUANT D-DIMER TEST SYSTEM (K062203) | Roche Diagnostics Corp. | 2007-03-14 |
| COBAS INTEGRA CERULOPLASMIN (K062379) | Roche Diagnostics Corp. | 2007-01-31 |
| CERULOPLASMIN, MODEL 2055953 (K062114) | Roche Diagnostics Corp. | 2007-01-31 |
| COAGUCHEK XS PT CONTROLS (K063823) | Roche Diagnostics Corp. | 2007-01-29 |
| COAGUCHEK XS SYSTEM (K062925) | Roche Diagnostics Corp. | 2007-01-29 |
| COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 (K063543) | Roche Diagnostics Corp. | 2006-12-22 |
| PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS (K062972) | Roche Diagnostics Corp. | 2006-10-13 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 (K062319) | Roche Diagnostics Corp. | 2006-09-13 |
| GLUCOSE HK NEW FORMULATION TEST SYSTEM (K062239) | Roche Diagnostics Corp. | 2006-09-11 |
| ONLINE TDM PROCAINAMIDE (K060773) | Roche Diagnostics Corp. | 2006-08-23 |
| TDM N-ACETYLPROCAINAMIDE (K060738) | Roche Diagnostics Corp. | 2006-08-16 |
| ACCU-CHEK AVIVA TEST STRIPS (K060620) | Roche Diagnostics Corp. | 2006-08-11 |
| COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K053287) | Roche Diagnostics Corp. | 2006-08-10 |
| COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K053289) | Roche Diagnostics Corp. | 2006-08-10 |
| ONLINE VALPROIC ACID (K060690) | Roche Diagnostics Corp. | 2006-08-08 |
| TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (K061683) | Roche Diagnostics Corp. | 2006-07-21 |
| CHOLINESTERASE GEN.2 TEST SYSTEM (K061093) | Roche Diagnostics Corp. | 2006-07-03 |
| ONLINE TDM TOBRAMYCIN (K060853) | Roche Diagnostics Corp. | 2006-06-09 |
| PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K060645) | Roche Diagnostics Corp. | 2006-05-30 |
| COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM (K061048) | Roche Diagnostics Corp. | 2006-05-17 |
| ENZYME IMMUNOASSAY, VANCOMYCIN (K060586) | Roche Diagnostics Corp. | 2006-05-11 |
| ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH (K060585) | Roche Diagnostics Corp. | 2006-05-03 |
| ELECSYS TSH CALSET W/MODELS 04738551 (K060754) | Roche Diagnostics Corp. | 2006-04-18 |
| ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK (K060755) | Roche Diagnostics Corp. | 2006-04-10 |
| TDM CONTROL SET (K060429) | Roche Diagnostics Corp. | 2006-03-15 |
| COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 (K060108) | Roche Diagnostics Corp. | 2006-02-16 |
| C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS (K053603) | Roche Diagnostics Corp. | 2006-02-09 |
| ROCHE ELECSYS ANTI-TG (K053426) | Roche Diagnostics Corp. | 2006-02-07 |
| ISE INDIRECT NA, K, CL FOR GEN.2 (K053165) | Roche Diagnostics Corp. | 2005-12-14 |
| ELECSYS PROBNP IMMUNOASSAY (K051382) | Roche Diagnostics Corp. | 2005-12-05 |
| ELECSYS PRECICONTROL BONE (K051543) | Roche Diagnostics Corp. | 2005-10-17 |
| TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST (K052464) | Roche Diagnostics Corp. | 2005-09-30 |
| ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K050760) | Roche Diagnostics Corp. | 2005-09-13 |
| ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK (K051297) | Roche Diagnostics Corp. | 2005-09-08 |
| MODIFICATION TO ACCU-CHEK GO SYSTEM (K051592) | Roche Diagnostics Corp. | 2005-09-02 |
| IRON STANDARD (K052002) | Roche Diagnostics Corp. | 2005-08-22 |
| ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (K051890) | Roche Diagnostics Corp. | 2005-08-04 |
| ELECSYS PRECICONTROL UNIVERSAL (K051687) | Roche Diagnostics Corp. | 2005-07-25 |
| ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET (K050231) | Roche Diagnostics Corp. | 2005-07-06 |
| ELECSYS CA 19-9 CALCHECK (K051185) | Roche Diagnostics Corp. | 2005-07-06 |
| ELECSYS PRECICONTROL ANEMIA (K051517) | Roche Diagnostics Corp. | 2005-07-05 |
| ELECSYS RBC FOLATE HEMOLYZED REAGENT (K051292) | Roche Diagnostics Corp. | 2005-06-17 |
| ACCU-CHEK INTEGRA SYSTEM (K050872) | Roche Diagnostics Corp. | 2005-05-02 |
| ACCU-CHEK AVIVA SYSTEM (K043474) | Roche Diagnostics Corp. | 2005-04-27 |
| ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR (K050387) | Roche Diagnostics Corp. | 2005-04-25 |
| ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE (K043529) | Roche Diagnostics Corp. | 2005-04-08 |
| ONLINE DAT PROPOXYPHENE PLUS (K043303) | Roche Diagnostics Corp. | 2005-03-11 |
| TINA-QUANT IGG GEN.2 (K050113) | Roche Diagnostics Corp. | 2005-02-08 |
| ONLINE DAT BENZODIAZEPINES PLUS (K043327) | Roche Diagnostics Corp. | 2005-02-07 |
| ONLINE DAT PHENCYCLIDINE PLUS (K043305) | Roche Diagnostics Corp. | 2005-01-10 |
| ONLINE DAT BARBITURATES PLUS (K043211) | Roche Diagnostics Corp. | 2004-12-29 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318) | Roche Diagnostics Corp. | 2004-12-23 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II (K043320) | Roche Diagnostics Corp. | 2004-12-17 |
| ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (K043175) | Roche Diagnostics Corp. | 2004-11-24 |
| ROCHE DIAGNOSTICS ELECSYS AFP CALSET II (K043095) | Roche Diagnostics Corp. | 2004-11-23 |
| TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) (K042485) | Roche Diagnostics Corp. | 2004-10-29 |
| ELECSYS FOLATE II CALSET II (K042490) | Roche Diagnostics Corp. | 2004-09-30 |
| MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K042389) | Roche Diagnostics Corp. | 2004-09-14 |
| ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS (K033491) | Roche Diagnostics Corp. | 2004-09-01 |
| MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) (K041812) | Roche Diagnostics Corp. | 2004-07-27 |
| MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K041227) | Roche Diagnostics Corp. | 2004-05-27 |
| ELECSYS TROPONIN T STAT TEST (K040733) | Roche Diagnostics Corp. | 2004-05-17 |
| BILIRUBIN ASSAY ON THE OMNI S ANALYZER (K040174) | Roche Diagnostics Corp. | 2004-05-14 |
| ACCU-CHEK GO SYSTEM (K040796) | Roche Diagnostics Corp. | 2004-04-22 |
| CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF (K040264) | Roche Diagnostics Corp. | 2004-04-02 |