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 |
|---|---|---|---|
| Jan 29, 1999 | K984152 | SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT Beckman Coulter, Inc. | DJG |
| Jan 22, 1999 | K984232 | MODIFICATION OF EMIT D.A.U. OPIATES ASSAY Syva Co. | DJG |
| Nov 18, 1998 | K983190 | DBEST OPIATES TEST KIT Ameritek, Inc. | DJG |
| Jun 12, 1998 | K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP Princeton BioMeditech Corp. | DJG |
| May 22, 1998 | K981341 | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) OraSure Technologies, Inc. | DJG |
| Apr 24, 1998 | K974840 | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL Roche Diagnostic Systems, Inc. | DJG |
| Dec 24, 1997 | K973761 | MICRO-STRIP FOR OPIATE METABOLITES Microdiagnostics, Inc. | DJG |
| Oct 28, 1997 | K973156 | UBI MAGIWEL COCAINE METABOLITES United Biotech, Inc. | DJG |
| Oct 28, 1997 | K973155 | UBI MAGIWEL OPIATE METABOLITES United Biotech, Inc. | DJG |
| Oct 28, 1997 | K973153 | UBI MAGIWEL AMPHETAMINE METABOLITES United Biotech, Inc. | DJG |
| Aug 20, 1997 | K972619 | QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) Phamatech | DJG |
| Aug 20, 1997 | K972571 | QUIKSTRIP ONE STEP OPIATES TEST Drial Consultants, Inc. | DJG |
| Aug 8, 1997 | K972405 | QUIKPAC II ONE STEP OPIATE TEST Drial Consultants, Inc. | DJG |
| Jun 25, 1997 | K971596 | EMIT II OPIATES 300/2000 ASSAY Behring Diagnostics, Inc. | DJG |
| Jun 6, 1997 | K971361 | AQ OPIATES (MORPHINE) TEST Bionike Laboratories, Inc. | DJG |
| Mar 10, 1997 | K962323 | IMMULITE OPIATES SCREEN/CONTROL MODULE Diagnostic Products Corp. | DJG |
| Oct 30, 1996 | K962795 | CEDIA DAU OPIATE 2K ASSAY Boehringer Mannheim Corp. | DJG |
| Mar 6, 1996 | K954498 | FRONTLINE OPIATES Boehringer Mannheim Corp. | DJG |
| Aug 17, 1995 | K952096 | ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) Tcpi, Inc. | DJG |
| Jul 14, 1995 | K935565 | OPIATES MICRO-PLATE ASSAY Solarcare Technologies Corp,Inc. | DJG |
| May 18, 1995 | K951287 | AXSYM OPIATES Abbott Laboratories | DJG |
| Apr 5, 1995 | K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | DJG |
| Feb 10, 1995 | K945608 | ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI Princeton BioMeditech Corp. | DJG |
| Jan 30, 1995 | K943248 | VISUALINE II MORPHINE/OPIATES/HEROIN Sun Biomedical Laboratories, Inc. | DJG |
| Jan 17, 1995 | K945343 | CEDIA DAU OPIATE ASSAY Microgenics Corp. | DJG |
| Nov 30, 1994 | K944606 | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS Beckman-Diagnostic Systems Group | DJG |
| Nov 17, 1994 | K943712 | VERDICT OPIATES Editek, Inc. | DJG |
| Nov 2, 1994 | K941041 | SOLOR CARE TECHNOLOGIES CORPORATION OPIATES Solar Technologies Corp. | DJG |
| Sep 7, 1994 | K941195 | CEDIA DAU OPIATE ASSAY Microgenics Corp. | DJG |
| Jan 11, 1994 | K935346 | CEDIA(R) DAU OPIATE ASSAY Microgenics Corp. | DJG |
| Jan 6, 1994 | K935117 | EMIT(R) IIC OPIATE ASSAY Syva Co. | DJG |
| Jun 15, 1993 | K932318 | USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 U.S. Drug Testing, Inc. | DJG |
| Oct 15, 1992 | K924446 | MICRO-PLATE OPIATES ASSAY Solarcare Technologies Corp,Inc. | DJG |
| Sep 15, 1992 | K923468 | MICRO EIA FOR OPIATE METABOLITES Microdiagnostics, Inc. | DJG |
| Aug 20, 1992 | K921328 | STC DIAGNOSTICS AUTO-LYTE OPIATE EIA Solarcare Technologies Corp,Inc. | DJG |
| Jan 22, 1992 | K915180 | OPIATE EIA ASSAY Diagnostic Reagents, Inc. | DJG |
| Nov 7, 1991 | K913742 | IL TEST(TM) OPIATE Instrumentation Laboratory CO | DJG |
| Sep 19, 1991 | K913863 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) Immunalysis Corporation | DJG |
| Mar 13, 1991 | K905491 | MICROLINE SCREEN FOR OPIATES Drug Screening Systems, Inc. | DJG |
| Dec 27, 1990 | K904997 | ABUSCREEN ONLINE TM FOR OPIATES Roche Diagnostic Systems, Inc. | DJG |
| Sep 14, 1990 | K902924 | BIOSITE DIAGNOSTICS OPIATE SCREENING TEST Biosite Incorporated | DJG |
| Jul 27, 1990 | K902577 | EMIT(R) II OPIATE ASSAY Syva Co. | DJG |
| Jul 17, 1990 | K902194 | MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT Immunotech Corp. | DJG |
| May 17, 1990 | K901577 | MILENIA(TM) OPIATES Diagnostic Products Corp. | DJG |
| Mar 30, 1990 | K900173 | HYCOR ACCUPINCH MORPHINE TEST Hycor Biomedical, Inc. | DJG |
| Mar 9, 1990 | K900203 | EZ-SCREEN:OPIATES Environmental Diagnostics, Inc. | DJG |
| Nov 17, 1989 | K890978 | TARGET OPIATES-R V-Tech, Inc. | DJG |
| Oct 4, 1989 | K890979 | TARGET OPIATES-V V-Tech, Inc. | DJG |
| Sep 28, 1989 | K891605 | COAT-A-COUNT(TM) FENTANYL (TKFN1) Diagnostic Products Corp. | DJG |
| Mar 15, 1989 | K890888 | ABUSCREEN FP FOR MORPHINE Roche Diagnostic Systems, Inc. | DJG |
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