Panels › Clinical Toxicology › Product code DJG · Class 2
Enzyme Immunoassay, Opiates
Regulation 862.3650
3510(k)s in 12 months (215 all time)
2recalls in 12 months (13 all time)
9recalls that name a 510(k)
Top companies in DJG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2006 | K060351 | MEDTOX OXYCODONE Medtox Diagnostics, Inc. | DJG |
| Apr 24, 2006 | K052520 | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC Tianjin New Bay Bioresearch Co., Ltd. | DJG |
| Apr 21, 2006 | K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE ACON Laboratories, Inc. | DJG |
| Oct 13, 2005 | K051626 | IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS Immunalysis Corporation | DJG |
| Jul 6, 2005 | K042725 | QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) Quest Diagnostics, Inc. | DJG |
| Jun 13, 2005 | K050733 | OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DJG |
| May 12, 2005 | K042988 | RAPID ONE STEP BUPRENORPHINE TEST CARD Tianjin New Bay Bioresearch Co., Ltd. | DJG |
| May 10, 2005 | K042990 | FOR SURE ONE STEP BUPRENORPHINE TEST STRIP Tianjin New Bay Bioresearch Co., Ltd. | DJG |
| Feb 25, 2005 | K043507 | ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE ACON Laboratories, Inc. | DJG |
| Feb 7, 2005 | K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 Phamatech, Inc. | DJG |
| Nov 24, 2004 | K041747 | IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) Lifepoint,Inc | DJG |
| Nov 23, 2004 | K041746 | IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) Lifepoint,Inc | DJG |
| Nov 3, 2004 | K041144 | RANDOX OPIATES ASSAY Randox Laboratories, Ltd., GB | DJG |
| Jun 23, 2004 | K040316 | CEDIA BUPRENORPHINE ASSAY Microgenics Corp. | DJG |
| May 3, 2004 | K040274 | ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE ACON Laboratories, Inc. | DJG |
| Feb 17, 2004 | K033047 | ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE ACON Laboratories, Inc. | DJG |
| Jul 14, 2003 | K031032 | VERDICT II, PROFILE II Medtox Diagnostics, Inc. | DJG |
| Jul 2, 2003 | K030113 | MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 Branan Medical Corp. | DJG |
| Apr 29, 2003 | K031002 | SYNCHRON SYSTEMS OPIATE REAGENT Beckman Coulter, Inc. | DJG |
| Nov 6, 2002 | K023047 | AMEDICA DRUG SCREEN OPIATES TEST Amedica Biotech, Inc. | DJG |
| Nov 5, 2002 | K020920 | COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE Cozart Bioscience , Ltd., GB | DJG |
| Jun 4, 2002 | K020368 | OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) Lin-Zhi International, Inc. | DJG |
| May 6, 2002 | K020716 | RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) Rapid Diagnostics, Inc. | DJG |
| Apr 3, 2002 | K020371 | UPLINK TEST SYSTEM OraSure Technologies, Inc. | DJG |
| Mar 20, 2002 | K014101 | RAPIDONE-OXY TEST American Bio Medica Corp. | DJG |
| Mar 13, 2002 | K013314 | OPIATES Abbott Laboratories | DJG |
| Dec 21, 2001 | K013482 | ABUSCREEN ONLINE OPIATES 300 / 2000 Roche Diagnostics Corp. | DJG |
| Dec 18, 2001 | K013380 | ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE ACON Laboratories, Inc. | DJG |
| Dec 6, 2001 | K013408 | AT HOME DRUG TEST, MODEL 9079 Phamatech, Inc. | DJG |
| Dec 6, 2001 | K013407 | AT HOME DRUG TEST, MODEL 9084 Phamatech, Inc. | DJG |
| Nov 30, 2001 | K012483 | AMEDITECH IMMUTEST DRUG SCREEN OPIATES Ameditech, Inc. | DJG |
| Jul 30, 2001 | K011353 | ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE ACON Laboratories, Inc. | DJG |
| Jun 20, 2001 | K011150 | DRIDAU OPIATE ASSAY Microgenics Corp. | DJG |
| May 15, 2001 | K011289 | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 Syva Co., Dade Behring, Inc. | DJG |
| Dec 11, 2000 | K000851 | PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR Psychemedics Corp. | DJG |
| Dec 5, 2000 | K003209 | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A Dade Behring, Inc. | DJG |
| Nov 27, 2000 | K002268 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST Branan Medical Corporation | DJG |
| Jun 9, 2000 | K001178 | CEDIA DAU 6-ACETYLMORPHINE ASSAY Microgenics Corp. | DJG |
| Apr 14, 2000 | K000464 | URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A Dade Behring, Inc. | DJG |
| Apr 7, 2000 | K000273 | SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST Drug Detection Devices, Ltd. | DJG |
| Jan 10, 2000 | K993151 | RADID DRUG SCREEN 5-PANEL TEST American Bio Medica Corp. | DJG |
| Dec 30, 1999 | K994234 | AT HOME DRUG TEST, MODEL 9083 Phamatech | DJG |
| Dec 16, 1999 | K992111 | VERDICT -II OPIATES 2000 Medtox Diagnostics, Inc. | DJG |
| Nov 23, 1999 | K992890 | ROCHE COBAS INTEGRA OPIATES 300/2000 Roche Diagnostics Corp. | DJG |
| Oct 29, 1999 | K993491 | QUICKPAC II ONE STEP OPIATES TEST Syntron Bioresearch, Inc. | DJG |
| Oct 29, 1999 | K993490 | QUICKSTRIP ONE STEP OPIATES TEST Syntron Bioresearch, Inc. | DJG |
| Oct 20, 1999 | K993165 | QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 Phamatech | DJG |
| Sep 15, 1999 | K991883 | REDI-TEST OPIATES Advantage Diagnostics Corp. | DJG |
| Aug 10, 1999 | K992422 | ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 Princeton BioMeditech Corp. | DJG |
| Jul 15, 1999 | K990820 | RAPIDONE - OPIATES TEST American Bio Medica Corp. | DJG |
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