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DIO

145 FDA 510(k) clearances · Product code

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RecordFirmDate
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC (K952361)Princeton BioMeditech Corp.1995-10-26
MECTEST (K945207)Meco Industries1995-09-25
ONE STEP URINE DRUG OF ABUSE COCAINE TEST (K951892)Tcpi, Inc.1995-08-17
AXSYM COCAINE METABOLITE (K951289)Abbott Laboratories1995-08-02
STC COCAINE METABOLITE EIA (K934775)Solarcare, Inc.1995-07-14
VISUALINE II COCAINE (K950369)Sun Biomedical Laboratories, Inc.1995-03-21
EMIT IIC COCAINE METABOLITE ASSAY (K935323)Syva Co.1995-02-22
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC (K945609)Princeton BioMeditech Corp.1995-02-22
CEDIA DAU COCAINE ASSAY (K945345)Microgenics Corp.1995-01-17
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC (K944231)Roche Diagnostic Systems, Inc.1994-12-02
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS (K944087)Beckman Instruments, Inc.1994-11-30
VERDICT COCAINE (K943710)Editek, Inc.1994-11-17
CEDIA DAU COCAINE ASSAY (K941310)Microgenics Corp.1994-06-02
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS (K935904)Microgenics Corp.1994-03-11
COCAINE METABOLITE EIA ASSAY MODIFICATION (K935016)Diagnostic Reagents, Inc.1993-12-03
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF (K933053)Roche Diagnostic Systems, Inc.1993-08-30
USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 (K930985)U.S. Drug Testing, Inc.1993-04-27
AUTOMATES COMA COCAINE METABOLITE ASSAY (K921834)Serex, Inc.1992-06-15
COCAINE METABOLITE EIA TEST (K915371)Diagnostic Reagents, Inc.1991-12-18
MICRO EIA FOR COCAINE METABOLITES (K914533)Microdiagnostics, Inc.1991-12-10
SYVA EMIT D.A.U. COCAINE METABOLITE (K914973)Syva Co.1991-11-29
MIRCOLINE SCREEN FOR COCAINE (K911652)Drug Screening Systems, Inc.1991-05-15
EMIT(R) II COCAINE METABOLITE ASSAY (K902579)Syva Co.1990-07-27
MICRO DAU COCAINE METABOLITE TEST KIT (K896781)Immunotech Corp.1990-03-23
HYCOR ACCUPINCH COCAINE TEST (K896937)Hycor Biomedical, Inc.1990-03-06
COMA COCAINE METABOLITE ASSAY (EIA) (K895043)Serex, Inc.1989-11-08
ADX COCAINE METABOLITE (K890788)Abbott Laboratories1989-08-25
ABUSCREEN FP BUFFER REAGENT (K890883)Roche Diagnostic Systems, Inc.1989-03-15
ABUSCREEN FP FOR COCAINE METABOLITE (K890885)Roche Diagnostic Systems, Inc.1989-03-13
EZ-SCREEN CANNABINOID/COCAINE (K883105)Environmental Diagnostics, Inc.1988-12-16
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE (K881815)Roche Diagnostic Systems, Inc.1988-07-29
EMIT HVA COCAINE METABOLITE ASSAY (K881942)Syva Co.1988-07-12
REVISED LABELING FOR ADX COCAINE METABOLITE (K880009)Abbott Laboratories1988-03-11
REVISED LABELING FOR TDX COCAINE METABOLITE (K874487)Abbott Laboratories1987-11-23
ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN (K874213)E.I. Dupont DE Nemours & Co., Inc.1987-11-13
REVISED LABELING FOR COCAINE/COCAINE META. TEST (K874271)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY (K874201)Syva Co.1987-10-28
LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE (K873751)Diagnostic Products Corp.1987-10-15
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY (K873752)Diagnostic Products Corp.1987-10-15
COCAINE METABOLITE ENZYME IMMUNOASSAY KIT (K871305)General Diagnostics1987-06-05
COCAINE METABOLITE ROCHE(R) EIA (K863843)Roche Diagnostic Systems, Inc.1987-03-16
TDX COCAINE METABOLITE (K854163)Abbott Laboratories1985-11-05
EMIT D.A.U. COCAINE ASSAY (K843556)Syva Co.1984-10-05
EMIT 700 COCAINE METABOLITE ASSAY (K843160)Syva Co.1984-08-29
EMIT ST. URINE COCAINE METABOLITE (K834549)Syva Co.1984-03-19
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Every clearance here is in the API, with alerts when new ones post.