| MEDTOX OXYCODONE (K060351) | Medtox Diagnostics, Inc. | 2006-05-12 |
| RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC (K052520) | Tianjin New Bay Bioresearch Co., Ltd. | 2006-04-24 |
| ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE (K060466) | ACON Laboratories, Inc. | 2006-04-21 |
| IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS (K051626) | Immunalysis Corporation | 2005-10-13 |
| QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) (K042725) | Quest Diagnostics, Inc. | 2005-07-06 |
| OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS (K050733) | Lin-Zhi International, Inc. | 2005-06-13 |
| RAPID ONE STEP BUPRENORPHINE TEST CARD (K042988) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-12 |
| FOR SURE ONE STEP BUPRENORPHINE TEST STRIP (K042990) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-10 |
| ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE (K043507) | ACON Laboratories, Inc. | 2005-02-25 |
| QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 (K043051) | Phamatech, Inc. | 2005-02-07 |
| IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) (K041747) | Lifepoint,Inc | 2004-11-24 |
| IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) (K041746) | Lifepoint,Inc | 2004-11-23 |
| RANDOX OPIATES ASSAY (K041144) | Randox Laboratories, Ltd. | 2004-11-03 |
| CEDIA BUPRENORPHINE ASSAY (K040316) | Microgenics Corp. | 2004-06-23 |
| ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE (K040274) | ACON Laboratories, Inc. | 2004-05-03 |
| ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE (K033047) | ACON Laboratories, Inc. | 2004-02-17 |
| VERDICT II, PROFILE II (K031032) | Medtox Diagnostics, Inc. | 2003-07-14 |
| MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 (K030113) | Branan Medical Corp. | 2003-07-02 |
| SYNCHRON SYSTEMS OPIATE REAGENT (K031002) | Beckman Coulter, Inc. | 2003-04-29 |
| AMEDICA DRUG SCREEN OPIATES TEST (K023047) | Amedica Biotech, Inc. | 2002-11-06 |
| COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE (K020920) | Cozart Bioscience , Ltd. | 2002-11-05 |
| OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) (K020368) | Lin-Zhi International, Inc. | 2002-06-04 |
| RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) (K020716) | Rapid Diagnostics, Inc. | 2002-05-06 |
| UPLINK TEST SYSTEM (K020371) | OraSure Technologies, Inc. | 2002-04-03 |
| RAPIDONE-OXY TEST (K014101) | American Bio Medica Corp. | 2002-03-20 |
| OPIATES (K013314) | Abbott Laboratories | 2002-03-13 |
| ABUSCREEN ONLINE OPIATES 300 / 2000 (K013482) | Roche Diagnostics Corp. | 2001-12-21 |
| ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE (K013380) | ACON Laboratories, Inc. | 2001-12-18 |
| AT HOME DRUG TEST, MODEL 9084 (K013407) | Phamatech, Inc. | 2001-12-06 |
| AT HOME DRUG TEST, MODEL 9079 (K013408) | Phamatech, Inc. | 2001-12-06 |
| AMEDITECH IMMUTEST DRUG SCREEN OPIATES (K012483) | Ameditech, Inc. | 2001-11-30 |
| ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE (K011353) | ACON Laboratories, Inc. | 2001-07-30 |
| DRIDAU OPIATE ASSAY (K011150) | Microgenics Corp. | 2001-06-20 |
| EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 (K011289) | Syva Co., Dade Behring, Inc. | 2001-05-15 |
| PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR (K000851) | Psychemedics Corp. | 2000-12-11 |
| URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A (K003209) | Dade Behring, Inc. | 2000-12-05 |
| BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST (K002268) | Branan Medical Corporation | 2000-11-27 |
| CEDIA DAU 6-ACETYLMORPHINE ASSAY (K001178) | Microgenics Corp. | 2000-06-09 |
| URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A (K000464) | Dade Behring, Inc. | 2000-04-14 |
| SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST (K000273) | Drug Detection Devices, Ltd. | 2000-04-07 |
| RADID DRUG SCREEN 5-PANEL TEST (K993151) | American Bio Medica Corp. | 2000-01-10 |
| AT HOME DRUG TEST, MODEL 9083 (K994234) | Phamatech | 1999-12-30 |
| VERDICT -II OPIATES 2000 (K992111) | Medtox Diagnostics, Inc. | 1999-12-16 |
| ROCHE COBAS INTEGRA OPIATES 300/2000 (K992890) | Roche Diagnostics Corp. | 1999-11-23 |
| QUICKSTRIP ONE STEP OPIATES TEST (K993490) | Syntron Bioresearch, Inc. | 1999-10-29 |
| QUICKPAC II ONE STEP OPIATES TEST (K993491) | Syntron Bioresearch, Inc. | 1999-10-29 |
| QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 (K993165) | Phamatech | 1999-10-20 |
| REDI-TEST OPIATES (K991883) | Advantage Diagnostics Corp. | 1999-09-15 |
| ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 (K992422) | Princeton BioMeditech Corp. | 1999-08-10 |
| RAPIDONE - OPIATES TEST (K990820) | American Bio Medica Corp. | 1999-07-15 |
| SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT (K984152) | Beckman Coulter, Inc. | 1999-01-29 |
| MODIFICATION OF EMIT D.A.U. OPIATES ASSAY (K984232) | Syva Co. | 1999-01-22 |
| DBEST OPIATES TEST KIT (K983190) | Ameritek, Inc. | 1998-11-18 |
| ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP (K981771) | Princeton BioMeditech Corp. | 1998-06-12 |
| STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) (K981341) | OraSure Technologies, Inc. | 1998-05-22 |
| ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL (K974840) | Roche Diagnostic Systems, Inc. | 1998-04-24 |
| MICRO-STRIP FOR OPIATE METABOLITES (K973761) | Microdiagnostics, Inc. | 1997-12-24 |
| UBI MAGIWEL OPIATE METABOLITES (K973155) | United Biotech, Inc. | 1997-10-28 |
| UBI MAGIWEL COCAINE METABOLITES (K973156) | United Biotech, Inc. | 1997-10-28 |
| UBI MAGIWEL AMPHETAMINE METABOLITES (K973153) | United Biotech, Inc. | 1997-10-28 |
| QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) (K972619) | Phamatech | 1997-08-20 |
| QUIKSTRIP ONE STEP OPIATES TEST (K972571) | Drial Consultants, Inc. | 1997-08-20 |
| QUIKPAC II ONE STEP OPIATE TEST (K972405) | Drial Consultants, Inc. | 1997-08-08 |
| EMIT II OPIATES 300/2000 ASSAY (K971596) | Behring Diagnostics, Inc. | 1997-06-25 |
| AQ OPIATES (MORPHINE) TEST (K971361) | Bionike Laboratories, Inc. | 1997-06-06 |
| IMMULITE OPIATES SCREEN/CONTROL MODULE (K962323) | Diagnostic Products Corp. | 1997-03-10 |
| CEDIA DAU OPIATE 2K ASSAY (K962795) | Boehringer Mannheim Corp. | 1996-10-30 |
| FRONTLINE OPIATES (K954498) | Boehringer Mannheim Corp. | 1996-03-06 |
| ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) (K952096) | Tcpi, Inc. | 1995-08-17 |
| OPIATES MICRO-PLATE ASSAY (K935565) | Solarcare Technologies Corp,Inc. | 1995-07-14 |
| AXSYM OPIATES (K951287) | Abbott Laboratories | 1995-05-18 |
| URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (K950136) | E.I. Dupont DE Nemours & Co., Inc. | 1995-04-05 |
| ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI (K945608) | Princeton BioMeditech Corp. | 1995-02-10 |
| VISUALINE II MORPHINE/OPIATES/HEROIN (K943248) | Sun Biomedical Laboratories, Inc. | 1995-01-30 |
| CEDIA DAU OPIATE ASSAY (K945343) | Microgenics Corp. | 1995-01-17 |
| CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS (K944606) | Beckman-Diagnostic Systems Group | 1994-11-30 |
| VERDICT OPIATES (K943712) | Editek, Inc. | 1994-11-17 |
| SOLOR CARE TECHNOLOGIES CORPORATION OPIATES (K941041) | Solar Technologies Corp. | 1994-11-02 |
| CEDIA DAU OPIATE ASSAY (K941195) | Microgenics Corp. | 1994-09-07 |
| CEDIA(R) DAU OPIATE ASSAY (K935346) | Microgenics Corp. | 1994-01-11 |
| EMIT(R) IIC OPIATE ASSAY (K935117) | Syva Co. | 1994-01-06 |
| USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 (K932318) | U.S. Drug Testing, Inc. | 1993-06-15 |
| MICRO-PLATE OPIATES ASSAY (K924446) | Solarcare Technologies Corp,Inc. | 1992-10-15 |
| MICRO EIA FOR OPIATE METABOLITES (K923468) | Microdiagnostics, Inc. | 1992-09-15 |
| STC DIAGNOSTICS AUTO-LYTE OPIATE EIA (K921328) | Solarcare Technologies Corp,Inc. | 1992-08-20 |
| OPIATE EIA ASSAY (K915180) | Diagnostic Reagents, Inc. | 1992-01-22 |
| IL TEST(TM) OPIATE (K913742) | Instrumentation Laboratory CO | 1991-11-07 |
| URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (K913863) | Immunalysis Corporation | 1991-09-19 |
| MICROLINE SCREEN FOR OPIATES (K905491) | Drug Screening Systems, Inc. | 1991-03-13 |
| ABUSCREEN ONLINE TM FOR OPIATES (K904997) | Roche Diagnostic Systems, Inc. | 1990-12-27 |
| BIOSITE DIAGNOSTICS OPIATE SCREENING TEST (K902924) | Biosite Incorporated | 1990-09-14 |
| EMIT(R) II OPIATE ASSAY (K902577) | Syva Co. | 1990-07-27 |
| MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT (K902194) | Immunotech Corp. | 1990-07-17 |
| MILENIA(TM) OPIATES (K901577) | Diagnostic Products Corp. | 1990-05-17 |
| HYCOR ACCUPINCH MORPHINE TEST (K900173) | Hycor Biomedical, Inc. | 1990-03-30 |
| EZ-SCREEN:OPIATES (K900203) | Environmental Diagnostics, Inc. | 1990-03-09 |
| TARGET OPIATES-R (K890978) | V-Tech, Inc. | 1989-11-17 |
| TARGET OPIATES-V (K890979) | V-Tech, Inc. | 1989-10-04 |
| COAT-A-COUNT(TM) FENTANYL (TKFN1) (K891605) | Diagnostic Products Corp. | 1989-09-28 |
| ABUSCREEN FP FOR MORPHINE (K890888) | Roche Diagnostic Systems, Inc. | 1989-03-15 |