| CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) (K040245) | Roche Diagnostics Corp. | 2004-03-24 |
| PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS (K040280) | Roche Diagnostics Corp. | 2004-03-11 |
| ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (K040434) | Roche Diagnostics Corp. | 2004-03-10 |
| ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (K040431) | Roche Diagnostics Corp. | 2004-03-10 |
| ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (K040435) | Roche Diagnostics Corp. | 2004-03-10 |
| ELECSYS C-PEPTIDE CALCHECK (K040157) | Roche Diagnostics Corp. | 2004-02-25 |
| ELECSYS C-PEPTIDE CALSET (K033873) | Roche Diagnostics Corp. | 2004-02-13 |
| ROCHE ONLINE TDM LIDOCAINE (K032334) | Roche Diagnostics Corp. | 2004-01-12 |
| ROCHE ONLINE TDM QUINIDINE (K032332) | Roche Diagnostics Corp. | 2004-01-12 |
| ELECSYS PRECICONTROL MULTIANALYTE (K033937) | Roche Diagnostics Corp. | 2004-01-07 |
| FACTOR II (PROTHROMBIN) G20210A KIT (K033612) | Roche Diagnostics Corp. | 2003-12-18 |
| FACTOR V LEIDEN KIT (DEN030005) | Roche Diagnostics Corp. | 2003-12-17 |
| LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734) | Roche Diagnostics Corp. | 2003-12-17 |
| PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K033306) | Roche Diagnostics Corp. | 2003-12-15 |
| HDL-CHOLESTEROL PLUS 2ND GENERATION (K033610) | Roche Diagnostics Corp. | 2003-12-05 |
| PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (K033246) | Roche Diagnostics Corp. | 2003-12-02 |
| ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER (K033548) | Roche Diagnostics Corp. | 2003-11-24 |
| MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) (K033501) | Roche Diagnostics Corp. | 2003-11-20 |
| ELECSYS PROBNP IMMUNOASSAY (K032646) | Roche Diagnostics Corp. | 2003-11-12 |
| ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311) | Roche Diagnostics Corp. | 2003-10-17 |
| ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 (K033009) | Roche Diagnostics Corp. | 2003-10-16 |
| COBAS INTEGRA ALP IFCC GEN.2 (K033185) | Roche Diagnostics Corp. | 2003-10-14 |
| PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS (K033165) | Roche Diagnostics Corp. | 2003-10-14 |
| ONLINE TDM AMIKA (K032279) | Roche Diagnostics Corp. | 2003-10-10 |
| CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS (K032437) | Roche Diagnostics Corp. | 2003-10-08 |
| ONLINE TDM CARBAMAZEPINE (K031902) | Roche Diagnostics Corp. | 2003-09-17 |
| ACCU-CHEK ADVANTAGE SYSTEM (K032552) | Roche Diagnostics Corp. | 2003-09-12 |
| MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K032535) | Roche Diagnostics Corp. | 2003-09-10 |
| ROCHE ONLINE TDM VALPROIC ACID (K032049) | Roche Diagnostics Corp. | 2003-08-22 |
| ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID (K032377) | Roche Diagnostics Corp. | 2003-08-21 |
| ELECSYS PRECICONTROL TROPONIN T (K031990) | Roche Diagnostics Corp. | 2003-08-20 |
| ELECYS SHBG CALCHECK (K031698) | Roche Diagnostics Corp. | 2003-08-20 |
| PRECISET TDM I AND PRECISET TDM II CALIBRATORS (K031856) | Roche Diagnostics Corp. | 2003-08-06 |
| PRECISET DAT PLUS I CALIBRATORS (K031775) | Roche Diagnostics Corp. | 2003-08-05 |
| ELECSYS SHBG IMMUNOASSAY (K031717) | Roche Diagnostics Corp. | 2003-08-05 |
| TINA-QUANT CRP (LATEX) (K032336) | Roche Diagnostics Corp. | 2003-08-05 |
| ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC (K032089) | Roche Diagnostics Corp. | 2003-07-30 |
| COBAS INTEGRA CARBON DIOXIDE ASSAY (K031879) | Roche Diagnostics Corp. | 2003-07-17 |
| FERRITIN GENERATION 2 (K031650) | Roche Diagnostics Corp. | 2003-07-17 |
| AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL (K031880) | Roche Diagnostics Corp. | 2003-07-16 |
| COBAS INTEGRA CHOLESTEROL GEN. 2 (K031824) | Roche Diagnostics Corp. | 2003-07-09 |
| ACCU-CHEK COMPACT TEST STRIP (K031755) | Roche Diagnostics Corp. | 2003-07-03 |
| ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY (K031756) | Roche Diagnostics Corp. | 2003-06-25 |
| COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING (K030845) | Roche Diagnostics Corp. | 2003-05-22 |
| ELECSYS LH CALSET II (K031299) | Roche Diagnostics Corp. | 2003-05-12 |
| ROCHE ONLINE TDM PHENYTOIN (K030428) | Roche Diagnostics Corp. | 2003-04-28 |
| ONLINE DAT II CANNABINOIDS II (K030213) | Roche Diagnostics Corp. | 2003-04-11 |
| MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM (K030740) | Roche Diagnostics Corp. | 2003-04-01 |
| COBAS INTEGRA CREATININE PLUS VER.2 ASSAY (K024098) | Roche Diagnostics Corp. | 2002-12-19 |
| ONLINE DAT II COCAINE II (K023281) | Roche Diagnostics Corp. | 2002-12-06 |
| ELECSYS PROBNP CALCHECK (K020883) | Roche Diagnostics Corp. | 2002-11-29 |
| COBAS INTEGRA ONLINE DAT II COCAINE II (K023296) | Roche Diagnostics Corp. | 2002-11-25 |
| ELECSYS PROBNP IMMUNOASSAY (K022516) | Roche Diagnostics Corp. | 2002-11-19 |
| PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 (K021190) | Roche Diagnostics Corp. | 2002-10-25 |
| PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 (K020831) | Roche Diagnostics Corp. | 2002-10-24 |
| ELECSYS CORTISOL TEST SYSTEM (K021218) | Roche Diagnostics Corp. | 2002-09-09 |
| MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (K022654) | Roche Diagnostics Corp. | 2002-08-29 |
| ELECSYS ANTI-TG TEST SYSTEM (K020672) | Roche Diagnostics Corp. | 2002-08-05 |
| ACCU-CHEK COMPACT SYSTEM (K022171) | Roche Diagnostics Corp. | 2002-07-23 |
| ONLINE DAT II METHADONE II (K021505) | Roche Diagnostics Corp. | 2002-07-16 |
| COBAS INTEGRA ONLINE DAT II METHADONE II (K021512) | Roche Diagnostics Corp. | 2002-07-16 |
| ROCHE ONLINE GENTAMICIN (K020704) | Roche Diagnostics Corp. | 2002-07-12 |
| MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021827) | Roche Diagnostics Corp. | 2002-07-03 |
| ACCU-CHEK ADVANTAGE MODULE (K021513) | Roche Diagnostics Corp. | 2002-06-11 |
| MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021448) | Roche Diagnostics Corp. | 2002-06-03 |
| ROCHE ONLINE THEOPHYLLINE (K020740) | Roche Diagnostics Corp. | 2002-04-16 |
| DIABETES ASSISTANT SOFTWARE (K014139) | Roche Diagnostics Corp. | 2002-03-21 |
| ELECSYS ANTI-TG CALCHECK (K020369) | Roche Diagnostics Corp. | 2002-03-06 |
| ROCHE ACETAMINOPHEN (K013757) | Roche Diagnostics Corp. | 2002-01-08 |
| ABUSCREEN ONLINE OPIATES 300 / 2000 (K013482) | Roche Diagnostics Corp. | 2001-12-21 |
| ACCU-CHEK ACTIVE TEST SYSTEM (K012324) | Roche Diagnostics Corp. | 2001-12-05 |
| INFLUENZA A/B RAPID TEST, CAT NO 2158 663 (K011684) | Roche Diagnostics Corp. | 2001-11-30 |
| TINA-QUANT COMPLEMENT C3C TEST SYSTEM (K012361) | Roche Diagnostics Corp. | 2001-11-29 |
| TINA-QUANT COMPLEMENT C4 TEST SYSTEM (K012359) | Roche Diagnostics Corp. | 2001-11-29 |
| TINA-QUANT APOLIPOPROTEIN VER.2 (K013249) | Roche Diagnostics Corp. | 2001-11-16 |
| TINA-QUANT APOLIPOPROTEIN B VER.2 (K013206) | Roche Diagnostics Corp. | 2001-11-16 |
| TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (K013278) | Roche Diagnostics Corp. | 2001-11-15 |
| TINA-QUANT APOLIPOPROTEIN B VER.2 (K013207) | Roche Diagnostics Corp. | 2001-11-13 |
| ONTRAK TESTCARD 9 (K012396) | Roche Diagnostics Corp. | 2001-11-05 |
| OMNI C ANALYZER (K013373) | Roche Diagnostics Corp. | 2001-11-02 |
| URISYS 2400 URINE TEST STRIP (K012397) | Roche Diagnostics Corp. | 2001-09-26 |
| TINA-QUANT TRANSFERRIN VER.2 (K012371) | Roche Diagnostics Corp. | 2001-09-19 |
| TINA-QUANT TRANSFERRIN VER.2 (K012393) | Roche Diagnostics Corp. | 2001-09-19 |
| MODIFICATION TO ELECSYS FSH II CALSET (K012399) | Roche Diagnostics Corp. | 2001-08-24 |
| MODIFICATION TO ACCU-CHEK INFORM METER (K012210) | Roche Diagnostics Corp. | 2001-08-09 |
| MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION (K012286) | Roche Diagnostics Corp. | 2001-08-08 |
| MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION (K012287) | Roche Diagnostics Corp. | 2001-08-07 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (K011226) | Roche Diagnostics Corp. | 2001-06-25 |
| MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 (K011145) | Roche Diagnostics Corp. | 2001-06-25 |
| ACCU-CHEK ACTIVE SYSTEM (K011738) | Roche Diagnostics Corp. | 2001-06-20 |
| TINA-QUANT D-DIMER TEST SYSTEM (K011143) | Roche Diagnostics Corp. | 2001-05-29 |
| CRP HS TEST SYSTEM (K003400) | Roche Diagnostics Corp. | 2001-05-10 |
| TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 (K003064) | Roche Diagnostics Corp. | 2001-05-01 |
| ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS (K004010) | Roche Diagnostics Corp. | 2001-04-26 |
| ELECSYSCA 15-3 II ASSAY (K010588) | Roche Diagnostics Corp. | 2001-03-28 |
| ACCU-CHEK INFORM METER (K003846) | Roche Diagnostics Corp. | 2001-03-19 |
| ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI (K002706) | Roche Diagnostics Corp. | 2001-03-16 |
| ACCU-CHEK COMFORT CURVE TEST STRIP (K010362) | Roche Diagnostics Corp. | 2001-03-07 |
| ELECSYS TESTOSTERONE CALSET II (K003411) | Roche Diagnostics Corp. | 2001-03-01 |
| COBAS INTEGRA AMPHETAMINES (K003865) | Roche Diagnostics Corp. | 2001-02-28 |