| MODIFICATION TO ABUSCREEN ONLINE BARBITURATES (K983698) | Roche Diagnostic Systems, Inc. | 1999-05-03 |
| MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES (K983702) | Roche Diagnostic Systems, Inc. | 1999-02-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (K983704) | Roche Diagnostic Systems, Inc. | 1999-02-10 |
| ABUSCREEN ONLINE BENZ 300 CALIBRATORS (K983556) | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| ABUSCREEN ONLINE BENZ 200 CALIBRATORS (K983555) | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (K983699) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (K983701) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (K983697) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (K983703) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (K983700) | Roche Diagnostic Systems, Inc. | 1998-12-11 |
| ONTRAK TESTCUP-ER (K983388) | Roche Diagnostic Systems, Inc. | 1998-11-18 |
| ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES (K983174) | Roche Diagnostic Systems, Inc. | 1998-11-18 |
| ONTRAK TESTCUP AND TESTSTIK CONTROLS (K983387) | Roche Diagnostic Systems, Inc. | 1998-10-09 |
| COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT (K982848) | Roche Diagnostic Systems, Inc. | 1998-10-01 |
| COBAS INTEGRA REAGENT CASSETTES (K982382) | Roche Diagnostic Systems, Inc. | 1998-09-28 |
| ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE (K981897) | Roche Diagnostic Systems, Inc. | 1998-08-26 |
| ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN (K982551) | Roche Diagnostic Systems, Inc. | 1998-08-18 |
| ROCHE CRP T CONTROL N (K982087) | Roche Diagnostic Systems, Inc. | 1998-08-18 |
| COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) (K980996) | Roche Diagnostic Systems, Inc. | 1998-06-05 |
| ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) (K981585) | Roche Diagnostic Systems, Inc. | 1998-05-28 |
| ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) (K981584) | Roche Diagnostic Systems, Inc. | 1998-05-28 |
| COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) (K974695) | Roche Diagnostic Systems, Inc. | 1998-05-21 |
| ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL (K974840) | Roche Diagnostic Systems, Inc. | 1998-04-24 |
| COBAS INTEGRA HDL-CHOLESTEROL DIRECT (K973284) | Roche Diagnostic Systems, Inc. | 1997-12-18 |
| ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) (K973369) | Roche Diagnostic Systems, Inc. | 1997-11-21 |
| ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON (K973075) | Roche Diagnostic Systems, Inc. | 1997-10-09 |
| ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION (K972891) | Roche Diagnostic Systems, Inc. | 1997-10-01 |
| ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K972250) | Roche Diagnostic Systems, Inc. | 1997-08-12 |
| ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P (K972721) | Roche Diagnostic Systems, Inc. | 1997-08-06 |
| ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) (K972214) | Roche Diagnostic Systems, Inc. | 1997-06-24 |
| ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT (K971902) | Roche Diagnostic Systems, Inc. | 1997-06-16 |
| ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (K964670) | Roche Diagnostic Systems, Inc. | 1997-02-04 |
| ROCHE COBAS IBTEGRA REAGENT CASSETTES (K964457) | Roche Diagnostic Systems, Inc. | 1997-01-13 |
| ONTRAK TESTCUP 5 (MODIFICATION) (K964355) | Roche Diagnostic Systems, Inc. | 1996-12-13 |
| ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL (K964422) | Roche Diagnostic Systems, Inc. | 1996-11-25 |
| COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K963292) | Roche Diagnostic Systems, Inc. | 1996-10-31 |
| (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE (K963627) | Roche Diagnostic Systems, Inc. | 1996-10-24 |
| ONTRAK TESTCUP AMPHETAMINES (K962411) | Roche Diagnostic Systems, Inc. | 1996-10-07 |
| ROCHE UNIMATE FRUCTOSAMINE REAGENT (K961674) | Roche Diagnostic Systems, Inc. | 1996-09-27 |
| COBAS CORE IMMUNOCHEMISTRY SYSTEM (K962231) | Roche Diagnostic Systems, Inc. | 1996-08-30 |
| ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR (K962280) | Roche Diagnostic Systems, Inc. | 1996-08-16 |
| COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN (K961824) | Roche Diagnostic Systems, Inc. | 1996-07-23 |
| ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 (K961726) | Roche Diagnostic Systems, Inc. | 1996-07-11 |
| COBAS-FP TDM CALIBRATION VERIFICATION TEST SET (K962165) | Roche Diagnostic Systems, Inc. | 1996-06-26 |
| ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (K961436) | Roche Diagnostic Systems, Inc. | 1996-06-21 |
| ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (K961620) | Roche Diagnostic Systems, Inc. | 1996-06-13 |
| ROCHE REAGENT FOR GLUCOSE (K953847) | Roche Diagnostic Systems, Inc. | 1996-02-13 |
| ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P (K952337) | Roche Diagnostic Systems, Inc. | 1996-02-09 |
| ROCHE COBAS INTEGRA REAGENT CASSETTES (K954992) | Roche Diagnostic Systems, Inc. | 1996-01-25 |
| ROCHE CONTROL SERUM N (K954655) | Roche Diagnostic Systems, Inc. | 1995-12-21 |
| ROCHE CONTROL SERUM P (K954656) | Roche Diagnostic Systems, Inc. | 1995-12-21 |
| ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL (K954799) | Roche Diagnostic Systems, Inc. | 1995-12-13 |
| COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID (K953224) | Roche Diagnostic Systems, Inc. | 1995-10-30 |
| ROCHE REAGENT FOR BUN (K954000) | Roche Diagnostic Systems, Inc. | 1995-10-25 |
| ROCHE COBAS MICROS HEMATOLOGY ANALYZER (K953448) | Roche Diagnostic Systems, Inc. | 1995-10-13 |
| ABUSCREEN ONLINE CONTROLS (K953739) | Roche Diagnostic Systems, Inc. | 1995-09-20 |
| ABUSCREEN ONLINE DRUG FREE URINE (K953845) | Roche Diagnostic Systems, Inc. | 1995-09-20 |
| ROCHE CALIBRATOR SERUM (K942706) | Roche Diagnostic Systems, Inc. | 1995-09-20 |
| ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR (K952282) | Roche Diagnostic Systems, Inc. | 1995-09-15 |
| ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN (K953528) | Roche Diagnostic Systems, Inc. | 1995-09-12 |
| ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES (K951595) | Roche Diagnostic Systems, Inc. | 1995-09-08 |
| COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS (K952555) | Roche Diagnostic Systems, Inc. | 1995-07-31 |
| ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION (K951319) | Roche Diagnostic Systems, Inc. | 1995-06-01 |
| COBAS CORE FREE T3 EIA (K942376) | Roche Diagnostic Systems, Inc. | 1995-04-21 |
| ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (K945187) | Roche Diagnostic Systems, Inc. | 1995-04-05 |
| COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (K945523) | Roche Diagnostic Systems, Inc. | 1995-03-09 |
| ROCHE-TDM ONLEIN(TM) CONTROLS (K946119) | Roche Diagnostic Systems, Inc. | 1995-02-07 |
| ABUSCREEN ONTRAK POSITIVE CONTROL (K943999) | Roche Diagnostic Systems, Inc. | 1995-01-25 |
| ABUSCREEN ONLINE(R) CALIBRATORS (K946000) | Roche Diagnostic Systems, Inc. | 1995-01-25 |
| ABUSCREEN ONLINE PROPOXPHENE (K945195) | Roche Diagnostic Systems, Inc. | 1994-12-09 |
| ABUSCREEN ONLINE CONTROLS (K945194) | Roche Diagnostic Systems, Inc. | 1994-12-09 |
| ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC (K944231) | Roche Diagnostic Systems, Inc. | 1994-12-02 |
| COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (K942847) | Roche Diagnostic Systems, Inc. | 1994-12-02 |
| ROCHE REAGENT (K941573) | Roche Diagnostic Systems, Inc. | 1994-10-31 |
| ROCHE AMMONIA (VARIOUS) (K942048) | Roche Diagnostic Systems, Inc. | 1994-10-04 |
| ROCHE TDM CALIBRATION VERIFICATION TEST SET (K942114) | Roche Diagnostic Systems, Inc. | 1994-09-02 |
| ROCHE REAGENT FOR CREATININE (K941837) | Roche Diagnostic Systems, Inc. | 1994-08-26 |
| ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) (K935055) | Roche Diagnostic Systems, Inc. | 1994-08-09 |
| COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (K941440) | Roche Diagnostic Systems, Inc. | 1994-07-06 |
| COBAS-FP REAGENTS AND CALIBRATORS (K941712) | Roche Diagnostic Systems, Inc. | 1994-06-13 |
| COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (K936130) | Roche Diagnostic Systems, Inc. | 1994-03-11 |
| COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (K936131) | Roche Diagnostic Systems, Inc. | 1994-03-11 |
| ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE (K930844) | Roche Diagnostic Systems, Inc. | 1994-01-27 |
| ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT (K935042) | Roche Diagnostic Systems, Inc. | 1994-01-25 |
| COBAS (R) CORE T4 EIA (K932605) | Roche Diagnostic Systems, Inc. | 1994-01-24 |
| COBAS(R) CORE FT4 EIA (K932607) | Roche Diagnostic Systems, Inc. | 1994-01-24 |
| ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK (K935550) | Roche Diagnostic Systems, Inc. | 1994-01-03 |
| ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS (K932548) | Roche Diagnostic Systems, Inc. | 1993-12-29 |
| COBAS CORE TSH EIA (K930776) | Roche Diagnostic Systems, Inc. | 1993-12-03 |
| COBAS(R) CORE T3 EIA (K932608) | Roche Diagnostic Systems, Inc. | 1993-12-03 |
| ROCHE ABUSCREEN ONLINE FOR METHADONE (K930928) | Roche Diagnostic Systems, Inc. | 1993-09-24 |
| COBAS CORE FSH EIA (K930304) | Roche Diagnostic Systems, Inc. | 1993-09-21 |
| ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED (K933052) | Roche Diagnostic Systems, Inc. | 1993-09-15 |
| ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF (K933053) | Roche Diagnostic Systems, Inc. | 1993-08-30 |
| ABUSCREEN ONLINE LOW-CUTOFF CONTROLS (K932549) | Roche Diagnostic Systems, Inc. | 1993-08-26 |
| COBAS CORE PROLACTIN EIA (K930305) | Roche Diagnostic Systems, Inc. | 1993-08-19 |
| ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR (K933279) | Roche Diagnostic Systems, Inc. | 1993-08-09 |
| COBAS(R) CORE IGE TOTAL EIA (K930890) | Roche Diagnostic Systems, Inc. | 1993-08-05 |
| ABUSCREEN ONLINE(R) CALIBRATORS (K931124) | Roche Diagnostic Systems, Inc. | 1993-08-03 |
| ABUSCREEN ONLINE CONTROL (K931125) | Roche Diagnostic Systems, Inc. | 1993-08-03 |