| ELECSYS HCG+B CALCHECK (K010237) | Roche Diagnostics Corp. | 2001-02-14 |
| ELECSYS FSH CALSET II (K003409) | Roche Diagnostics Corp. | 2001-01-26 |
| ELECSYS HCG STAT CLASET II (K003941) | Roche Diagnostics Corp. | 2001-01-25 |
| ELECSYS DHEA-S (K003174) | Roche Diagnostics Corp. | 2001-01-17 |
| CA 125 II CALCHECK (K003967) | Roche Diagnostics Corp. | 2001-01-12 |
| ELECSYS CA 125 II CALSET (K003969) | Roche Diagnostics Corp. | 2001-01-12 |
| ELECSYS DHEA-S CALCHECK (K003772) | Roche Diagnostics Corp. | 2000-12-20 |
| ROCHE DIAGNOSTICS CK-MB (K003158) | Roche Diagnostics Corp. | 2000-12-18 |
| MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C (K003120) | Roche Diagnostics Corp. | 2000-12-18 |
| ELECSYS HCG AND BETA TEST SYSTEM (K003178) | Roche Diagnostics Corp. | 2000-12-14 |
| CREATININE PLUS (K003261) | Roche Diagnostics Corp. | 2000-11-16 |
| ELECSYS CA 15-3 TEST SYSTEM (K001468) | Roche Diagnostics Corp. | 2000-10-23 |
| ELECSYS DHEA-S CALSET (K002760) | Roche Diagnostics Corp. | 2000-10-05 |
| COAGUCHEK S SYSTEM, MODEL 2138280 (K994349) | Roche Diagnostics Corp. | 2000-09-06 |
| CAMIT DIABETES MANAGEMENT SOFTWARE (K001907) | Roche Diagnostics Corp. | 2000-09-05 |
| TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K002609) | Roche Diagnostics Corp. | 2000-09-05 |
| ELECSYS HCG TEST SYSTEM (K002148) | Roche Diagnostics Corp. | 2000-08-22 |
| ELECSYS CA 15-3 CALCHECK (K002353) | Roche Diagnostics Corp. | 2000-08-10 |
| HDL CHOLESTEROL PLUS (K000568) | Roche Diagnostics Corp. | 2000-08-04 |
| ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (K993706) | Roche Diagnostics Corp. | 2000-07-24 |
| ELECSYS INSULIN CALSET (K001906) | Roche Diagnostics Corp. | 2000-07-13 |
| ONTRAK TESTCUP 501, MODEL 3016633 (K001421) | Roche Diagnostics Corp. | 2000-07-12 |
| ONTRAK TESTCUP PRO-5, MODEL 1986678 (K001356) | Roche Diagnostics Corp. | 2000-07-10 |
| ONTRAK TESTCUP 502, MODEL 3016641 (K001417) | Roche Diagnostics Corp. | 2000-06-29 |
| ELECSYS INSULIN CALCHECK (K001846) | Roche Diagnostics Corp. | 2000-06-28 |
| ELECSYS ANTI-TPO CALCHECK (K001014) | Roche Diagnostics Corp. | 2000-06-01 |
| THE CARDIAC READER SYSTEM (K000784) | Roche Diagnostics Corp. | 2000-05-18 |
| ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM (K000155) | Roche Diagnostics Corp. | 2000-05-17 |
| ELECSYS THYROGLOBULIN CALCHECK (K001015) | Roche Diagnostics Corp. | 2000-04-27 |
| ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 (K000096) | Roche Diagnostics Corp. | 2000-04-26 |
| ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 (K994164) | Roche Diagnostics Corp. | 2000-04-13 |
| ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 (K994165) | Roche Diagnostics Corp. | 2000-04-07 |
| COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II (K000534) | Roche Diagnostics Corp. | 2000-04-05 |
| ELECSYS CORTISOL CALCHECK (K000576) | Roche Diagnostics Corp. | 2000-03-21 |
| ELECSYS B-CROSSLAPS CALCHECK (K000042) | Roche Diagnostics Corp. | 2000-03-17 |
| ELECSYS CORTISOL TEST SYSTEM (K000270) | Roche Diagnostics Corp. | 2000-03-07 |
| ACCU-CHEK COMPLETE METER (K000364) | Roche Diagnostics Corp. | 2000-02-23 |
| ACCU-CHEK ADVANTAGE METER (K000365) | Roche Diagnostics Corp. | 2000-02-23 |
| ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 (K994020) | Roche Diagnostics Corp. | 2000-01-27 |
| ONTRAK TESTCUP 5, CAT. 07 6481 7 (K994030) | Roche Diagnostics Corp. | 2000-01-27 |
| ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 (K994017) | Roche Diagnostics Corp. | 2000-01-27 |
| ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM (K992851) | Roche Diagnostics Corp. | 2000-01-14 |
| ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST (K993048) | Roche Diagnostics Corp. | 1999-12-20 |
| ACCU-CHEK SIMPLICITY SYSTEM (K993829) | Roche Diagnostics Corp. | 1999-12-09 |
| ELECSYS PARATHYROID HORMONE CALCHECK (K993642) | Roche Diagnostics Corp. | 1999-11-30 |
| PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K993360) | Roche Diagnostics Corp. | 1999-11-24 |
| PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K992900) | Roche Diagnostics Corp. | 1999-11-24 |
| ROCHE COBAS INTEGRA OPIATES 300/2000 (K992890) | Roche Diagnostics Corp. | 1999-11-23 |
| PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM (K992492) | Roche Diagnostics Corp. | 1999-11-02 |
| INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC (K990992) | Roche Diagnostics Corp. | 1999-09-30 |
| ELECSYS PARATHYROID HORMONE TEST SYSTEM (K992680) | Roche Diagnostics Corp. | 1999-09-28 |
| ELECSYS ESTRADIOL CALSET II (K992981) | Roche Diagnostics Corp. | 1999-09-24 |
| COBAS INTEGRA ACETAMINOPHEN (K991598) | Roche Diagnostics Corp. | 1999-07-22 |
| COBAS INTEGRA AMIKACIN MAB (K991597) | Roche Diagnostics Corp. | 1999-07-22 |
| ROCHE COBAS INTEGRA SERUM BARBITURATES (K991440) | Roche Diagnostics Corp. | 1999-06-22 |
| ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) (K991443) | Roche Diagnostics Corp. | 1999-06-22 |
| ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 (K990399) | Roche Diagnostics Corp. | 1999-04-15 |
| ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) (K990409) | Roche Diagnostics Corp. | 1999-04-15 |
| INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (K990594) | Roche Diagnostics Corp. | 1999-04-14 |
| INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B (K990595) | Roche Diagnostics Corp. | 1999-04-14 |
| ONTRAK TESTCUP-ER M2K (K990418) | Roche Diagnostics Corp. | 1999-04-13 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) (K990460) | Roche Diagnostics Corp. | 1999-03-22 |
| ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV (K990377) | Roche Diagnostics Corp. | 1999-02-26 |
| ONTRAK TESTCUP-5 M2K (K990337) | Roche Diagnostics Corp. | 1999-02-23 |