Panels › Clinical Toxicology › Product code DIO · Class 2
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation 862.3250
0510(k)s in 12 months (145 all time)
0recalls in 12 months (23 all time)
12recalls that name a 510(k)
Top companies in DIO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 26, 1995 | K945549 | ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET Princeton BioMeditech Corp. | DIO |
| Sep 25, 1995 | K945207 | MECTEST Meco Industries | DIO |
| Aug 17, 1995 | K951892 | ONE STEP URINE DRUG OF ABUSE COCAINE TEST Tcpi, Inc. | DIO |
| Aug 2, 1995 | K951289 | AXSYM COCAINE METABOLITE Abbott Laboratories | DIO |
| Jul 14, 1995 | K934775 | STC COCAINE METABOLITE EIA Solarcare, Inc. | DIO |
| Mar 21, 1995 | K950369 | VISUALINE II COCAINE Sun Biomedical Laboratories, Inc. | DIO |
| Feb 22, 1995 | K945609 | ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC Princeton BioMeditech Corp. | DIO |
| Feb 22, 1995 | K935323 | EMIT IIC COCAINE METABOLITE ASSAY Syva Co. | DIO |
| Jan 17, 1995 | K945345 | CEDIA DAU COCAINE ASSAY Microgenics Corp. | DIO |
| Dec 2, 1994 | K944231 | ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC Roche Diagnostic Systems, Inc. | DIO |
| Nov 30, 1994 | K944087 | CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS Beckman Instruments, Inc. | DIO |
| Nov 17, 1994 | K943710 | VERDICT COCAINE Editek, Inc. | DIO |
| Jun 2, 1994 | K941310 | CEDIA DAU COCAINE ASSAY Microgenics Corp. | DIO |
| Mar 11, 1994 | K935904 | CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS Microgenics Corp. | DIO |
| Dec 3, 1993 | K935016 | COCAINE METABOLITE EIA ASSAY MODIFICATION Diagnostic Reagents, Inc. | DIO |
| Aug 30, 1993 | K933053 | ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF Roche Diagnostic Systems, Inc. | DIO |
| Apr 27, 1993 | K930985 | USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 U.S. Drug Testing, Inc. | DIO |
| Jun 15, 1992 | K921834 | AUTOMATES COMA COCAINE METABOLITE ASSAY Serex, Inc. | DIO |
| Dec 18, 1991 | K915371 | COCAINE METABOLITE EIA TEST Diagnostic Reagents, Inc. | DIO |
| Dec 10, 1991 | K914533 | MICRO EIA FOR COCAINE METABOLITES Microdiagnostics, Inc. | DIO |
| Nov 29, 1991 | K914973 | SYVA EMIT D.A.U. COCAINE METABOLITE Syva Co. | DIO |
| May 15, 1991 | K911652 | MIRCOLINE SCREEN FOR COCAINE Drug Screening Systems, Inc. | DIO |
| Jul 27, 1990 | K902579 | EMIT(R) II COCAINE METABOLITE ASSAY Syva Co. | DIO |
| Mar 23, 1990 | K896781 | MICRO DAU COCAINE METABOLITE TEST KIT Immunotech Corp. | DIO |
| Mar 6, 1990 | K896937 | HYCOR ACCUPINCH COCAINE TEST Hycor Biomedical, Inc. | DIO |
| Nov 8, 1989 | K895043 | COMA COCAINE METABOLITE ASSAY (EIA) Serex, Inc. | DIO |
| Aug 25, 1989 | K890788 | ADX COCAINE METABOLITE Abbott Laboratories | DIO |
| Mar 15, 1989 | K890883 | ABUSCREEN FP BUFFER REAGENT Roche Diagnostic Systems, Inc. | DIO |
| Mar 13, 1989 | K890885 | ABUSCREEN FP FOR COCAINE METABOLITE Roche Diagnostic Systems, Inc. | DIO |
| Dec 16, 1988 | K883105 | EZ-SCREEN CANNABINOID/COCAINE Environmental Diagnostics, Inc. | DIO |
| Jul 29, 1988 | K881815 | ABUSCREEN(R) ONTRAK(TM) FOR COCAINE Roche Diagnostic Systems, Inc. | DIO |
| Jul 12, 1988 | K881942 | EMIT HVA COCAINE METABOLITE ASSAY Syva Co. | DIO |
| Mar 11, 1988 | K880009 | REVISED LABELING FOR ADX COCAINE METABOLITE Abbott Laboratories | DIO |
| Nov 23, 1987 | K874487 | REVISED LABELING FOR TDX COCAINE METABOLITE Abbott Laboratories | DIO |
| Nov 13, 1987 | K874271 | REVISED LABELING FOR COCAINE/COCAINE META. TEST Roche Diagnostic Systems, Inc. | DIO |
| Nov 13, 1987 | K874213 | ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN E.I. Dupont DE Nemours & Co., Inc. | DIO |
| Oct 28, 1987 | K874201 | REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY Syva Co. | DIO |
| Oct 15, 1987 | K873752 | LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY Diagnostic Products Corp. | DIO |
| Oct 15, 1987 | K873751 | LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE Diagnostic Products Corp. | DIO |
| Jun 5, 1987 | K871305 | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT General Diagnostics | DIO |
| Mar 16, 1987 | K863843 | COCAINE METABOLITE ROCHE(R) EIA Roche Diagnostic Systems, Inc. | DIO |
| Nov 5, 1985 | K854163 | TDX COCAINE METABOLITE Abbott Laboratories | DIO |
| Oct 5, 1984 | K843556 | EMIT D.A.U. COCAINE ASSAY Syva Co. | DIO |
| Aug 29, 1984 | K843160 | EMIT 700 COCAINE METABOLITE ASSAY Syva Co. | DIO |
| Mar 19, 1984 | K834549 | EMIT ST. URINE COCAINE METABOLITE Syva Co. | DIO |
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