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 |
|---|---|---|---|
| Jun 10, 2002 | K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC Princeton BioMeditech Corp. | DIO |
| May 15, 2002 | K020771 | ACON ONE STEP DRUG SCREEN TEST CARD ACON Laboratories, Inc. | DIO |
| May 10, 2002 | K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) Lin-Zhi International, Inc. | DIO |
| Mar 28, 2002 | K020441 | EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY Dade Behring, Inc. | DIO |
| Mar 13, 2002 | K013004 | COCAINE Abbott Laboratories | DIO |
| Oct 22, 2001 | K011814 | AMEDITECH IMMUTEST DRUG SCREEN COC Ameditech, Inc. | DIO |
| Aug 9, 2001 | K011962 | ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST Advantage Diagnostics Corp., GB | DIO |
| Jul 30, 2001 | K011054 | RADS Chason Healthcare, LLC | DIO |
| Jul 9, 2001 | K010841 | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE ACON Laboratories, Inc. | DIO |
| Jun 25, 2001 | K010239 | COCAINE DIPSTICK TEST, MODEL D747-A Teco Diagnostics | DIO |
| May 2, 2001 | K011162 | MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY Syva Co., Dade Behring, Inc. | DIO |
| Apr 17, 2001 | K010967 | LIVESURE COCAINE SCREEN TEST Pan Probe Biotech, Inc. | DIO |
| Apr 11, 2001 | K010833 | AT WORK DRUG TEST, MODEL 9177T AWT Phamatech | DIO |
| Mar 30, 2001 | K010650 | AT HOME DRUG TEST, MODEL 9073 T Phamatech | DIO |
| Jan 22, 2001 | K003708 | ADVANTAGE THC/COCAINE TEST Advantage Diagnostics Corp. | DIO |
| Nov 27, 2000 | K002264 | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST Branan Medical Corporation | DIO |
| Aug 14, 2000 | K994403 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DIO |
| Jul 27, 2000 | K994398 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DIO |
| May 11, 2000 | K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA OraSure Technologies, Inc. | DIO |
| Apr 14, 2000 | K000467 | URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A Dade Behring, Inc. | DIO |
| Apr 11, 2000 | K000350 | SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST Drug Detection Devices, Ltd. | DIO |
| Apr 7, 2000 | K994165 | ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 Roche Diagnostics Corp. | DIO |
| Jan 27, 2000 | K993988 | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL Syva Co. | DIO |
| Dec 30, 1999 | K994219 | AT HOME DRUG TEST, MODEL 9073 Phamatech | DIO |
| Dec 27, 1999 | K993485 | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE Sun Biomedical Laboratories, Inc. | DIO |
| Sep 20, 1999 | K992990 | QUICKPAC II ONE STEP COCAINE TEST Syntron Bioresearch, Inc. | DIO |
| Sep 2, 1999 | K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE Syntron Bioresearch, Inc. | DIO |
| Jul 26, 1999 | K991110 | REDI-TEST COCAINE Redwood Biotech, Inc. | DIO |
| Jul 22, 1999 | K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM Syntron Bioresearch, Inc. | DIO |
| Jul 15, 1999 | K990822 | RAPIDONE - COCAINE TEST American Bio Medica Corp. | DIO |
| Dec 11, 1998 | K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE Roche Diagnostic Systems, Inc. | DIO |
| Nov 20, 1998 | K982759 | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U OraSure Technologies, Inc. | DIO |
| Nov 18, 1998 | K983388 | ONTRAK TESTCUP-ER Roche Diagnostic Systems, Inc. | DIO |
| Nov 18, 1998 | K983191 | DBEST COCAINE TEST KIT Ameritek, Inc. | DIO |
| Aug 25, 1998 | K982061 | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) OraSure Technologies, Inc. | DIO |
| May 29, 1998 | K981388 | MICRO-STRIP FOR COCAINE METABOLITES Microdiagnostics, Inc. | DIO |
| Apr 24, 1998 | K973986 | MECTEST Meco Industries | DIO |
| Mar 27, 1998 | K980153 | DRUG CHECK Texas Immunology, Inc. | DIO |
| Mar 20, 1998 | K980872 | RAPID DRUG SCREEN' 8 PANEL American Bio Medica Corp. | DIO |
| Jan 2, 1998 | K973651 | STC COCAINE METABOLITE MICRO-PLATE EIA OraSure Technologies, Inc. | DIO |
| Aug 28, 1997 | K972059 | QUIKPAC II ONE STEP COCAINE TEST Drial Consultants, Inc. | DIO |
| Aug 6, 1997 | K972384 | AQ ONE STEP COCAINE TEST Bionike Laboratories, Inc. | DIO |
| Jul 14, 1997 | K971926 | QUIKSTRIP ONE STEP COCAINE TEST Drial Consultants, Inc. | DIO |
| Apr 14, 1997 | K964900 | RAPID DRUG SCREEN American Bio Medica Corp. | DIO |
| Apr 8, 1997 | K963918 | IMMULITE COCAINE METABOLITE Diagnostic Products Corp. | DIO |
| Aug 19, 1996 | K962353 | ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) Princeton BioMeditech Corp. | DIO |
| Apr 2, 1996 | K960187 | COCAINE METABOLITE EIA TEST Diagnostic Reagents, Inc. | DIO |
| Mar 6, 1996 | K954496 | FRONTLINE COCAINE Boehringer Mannheim Corp. | DIO |
| Nov 3, 1995 | K954571 | ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI Princeton BioMeditech Corp. | DIO |
| Oct 26, 1995 | K952361 | ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC Princeton BioMeditech Corp. | DIO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.