Panels › Clinical Toxicology › Product code DIS · Class 2
Enzyme Immunoassay, Barbiturate
Regulation 862.3150
0510(k)s in 12 months (100 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in DIS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 1996 | K963529 | VERDICT BARBITURATES Editek, Inc. | DIS |
| Aug 15, 1996 | K962669 | ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY Princeton BioMeditech Corp. | DIS |
| Jun 28, 1996 | K961010 | ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD Princeton BioMeditech Corp. | DIS |
| May 6, 1996 | K960664 | BARBITURATE SERUM TOX EIA ASSAY Diagnostic Reagents, Inc. | DIS |
| Mar 11, 1996 | K955928 | BARBITURATE EIA ESSAY (MODIFICATION) Diagnostic Reagents, Inc. | DIS |
| Dec 11, 1995 | K953021 | ACS PHENOBARBITAL Ciba Corning Diagnostics Corp. | DIS |
| May 18, 1995 | K951253 | AXSYM BARBITURATES II U Abbott Laboratories | DIS |
| Apr 13, 1995 | K950137 | URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | DIS |
| Feb 22, 1995 | K935116 | EMIT IIC BARBITURATE ASSAY Syva Co. | DIS |
| Dec 29, 1994 | K944075 | CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST Beckman Instruments, Inc. | DIS |
| Dec 28, 1994 | K945344 | CEDIA DAU BARBITURATE ASSAY Microgenics Corp. | DIS |
| Aug 30, 1994 | K942436 | CEDIA DAU BARBITURATE ASSAY Microgenics Corp. | DIS |
| Jul 28, 1994 | K942404 | CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION Microgenics Corp. | DIS |
| Jul 18, 1994 | K941489 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. | DIS |
| Mar 22, 1994 | K936030 | CEDIA DAU BARBITURATE ASSAY Microgenics Corp. | DIS |
| Dec 7, 1993 | K934376 | STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA Solarcare, Inc. | DIS |
| Oct 29, 1993 | K933480 | MICROLINE SCREEN FOR BARBITURATES Drug Screening Systems, Inc. | DIS |
| Jun 15, 1993 | K931535 | EMIT(R) D.A.U. BARBITURATE ASSAY Syva Co. | DIS |
| Jan 12, 1993 | K926068 | EMIT(R) II BARBITURATE ASSAY Syva Co. | DIS |
| Dec 30, 1992 | K925491 | BARBITURATE EIA TEST Diagnostic Reagents, Inc. | DIS |
| Aug 5, 1992 | K920525 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL Biotrack, Inc. | DIS |
| Apr 24, 1992 | K920417 | IL TEST BARBITURATE, 35289 Instrumentation Laboratory CO | DIS |
| Apr 17, 1992 | K920314 | TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) Syntex Corp. | DIS |
| Nov 28, 1990 | K905057 | EZ-SCREEN:BARBITURATES Environmental Diagnostics, Inc. | DIS |
| Sep 27, 1990 | K903825 | DRUG OF ABUSE ANALYSIS SYSTEM Technicon Instruments Corp. | DIS |
| Jul 19, 1990 | K902580 | EMIT(R) II BARBITURATE ASSAY Syva Co. | DIS |
| Dec 19, 1989 | K896550 | TDX(R) BARBITURATES II ASSAY Abbott Laboratories | DIS |
| Aug 25, 1989 | K890690 | ADX TM BARBITURATES Abbott Laboratories | DIS |
| May 16, 1989 | K892650 | TDX BARBITURATES SERUM Abbott Laboratories | DIS |
| Mar 9, 1989 | K890884 | ABUSCREEN FP FOR BARBITURATES Roche Diagnostic Systems, Inc. | DIS |
| Sep 19, 1988 | K882663 | BARBITURATE ENZYME IMMUNOASSAY KIT General Diagnostics | DIS |
| Aug 8, 1988 | K882611 | EMIT HVA BARBITURATE ASSAY Syva Co. | DIS |
| Mar 1, 1988 | K880012 | REVISED LABELING FOR ADX BARBITURATES Abbott Laboratories | DIS |
| Jan 5, 1988 | K874702 | REVISED LABELING FOR SYVA BARBITURATE ASSAYS Syva Co. | DIS |
| Nov 23, 1987 | K874483 | REVISED LABELING FOR TDX BARBITURATES Abbott Laboratories | DIS |
| Nov 13, 1987 | K874266 | REVISED LABELING FOR BARBITURATE TEST KIT Roche Diagnostic Systems, Inc. | DIS |
| Nov 13, 1987 | K874210 | REVISED LABELING FOR ABUSCREEN EIA BARBITURATE Roche Diagnostic Systems, Inc. | DIS |
| Oct 20, 1987 | K873623 | ACA URINE BARBITURATES SCREEN METHOD E.I. Dupont DE Nemours & Co., Inc. | DIS |
| Oct 15, 1987 | K873754 | LABELING CHANGE BARBITURATES IN URINE Diagnostic Products Corp. | DIS |
| Mar 31, 1987 | K864993 | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE General Diagnostics | DIS |
| Mar 19, 1987 | K870936 | COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5 Diagnostic Products Corp. | DIS |
| Mar 16, 1987 | K870378 | ABUSCREEN (R) EIA BARBITURATE Roche Diagnostic Systems, Inc. | DIS |
| Sep 26, 1984 | K842675 | EMIT D.A.U. BARBITURATE ASSAY Syva Co. | DIS |
| Sep 14, 1984 | K843418 | EMIT 700 BARBITURATE ASSAY Syva Co. | DIS |
| Sep 7, 1984 | K842783 | ACA BARBITURATES SCREEN ANALY TEST PACK E.I. Dupont DE Nemours & Co., Inc. | DIS |
| Mar 19, 1984 | K840194 | EMIT ST SERUM BARBITURATE ASSAY Syva Co. | DIS |
| Jan 26, 1984 | K833577 | MODIF. OF EMIT URINE BARBITURATE Syva Co. | DIS |
| Apr 3, 1981 | K810602 | EMIT-ST SERUM BARBITURATE ASSAY Syva Co. | DIS |
| Oct 31, 1980 | K802617 | EMIT-STM BARBITURATE ASSAY Syva Co. | DIS |
| Dec 4, 1979 | K792114 | EMIT-BARBITURATE ASSAY Syva Co. | DIS |
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