Panels › Clinical Toxicology › Product code DKB · Class 2
Calibrators, Drug Mixture
Regulation 862.3200
0510(k)s in 12 months (94 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in DKB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 1992 | K923340 | ROCHE ABUSCREEN ONLINNE CALIBRATORS Roche Diagnostic Systems, Inc. | DKB |
| Mar 4, 1992 | K920208 | URINE A CALIBRATOR Diagnostic Reagents, Inc. | DKB |
| Nov 29, 1991 | K915003 | EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) Syva Co. | DKB |
| Oct 21, 1991 | K913741 | IL TEST(TM) DAT CAL/CONTROL SET C Instrumentation Laboratory CO | DKB |
| Oct 21, 1991 | K913740 | IL TEST(TM) DAT CAL/CONTROL SET B Instrumentation Laboratory CO | DKB |
| Sep 13, 1991 | K910881 | CONTROL AND LINEARITY Gds Diagnostics | DKB |
| Sep 10, 1991 | K913739 | IL TEST(TM) DAT CALIBRATOR A( -) Instrumentation Laboratory CO | DKB |
| Aug 26, 1991 | K913335 | ABUSCREEN(R) ONLINE(TM) CALIBRATORS Roche Diagnostic Systems, Inc. | DKB |
| Jul 22, 1991 | K912729 | EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) Syva Co. | DKB |
| Mar 11, 1991 | K910085 | ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS Roche Diagnostic Systems, Inc. | DKB |
| Feb 4, 1991 | K910087 | ABUSCREEN ONLINE OPIATES CALIBRATORS Roche Diagnostic Systems, Inc. | DKB |
| Feb 4, 1991 | K905828 | ABUSCREEN(R) ONLINE CALIBRATORS Roche Diagnostic Systems, Inc. | DKB |
| Nov 20, 1990 | K904764 | EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) Syva Co. | DKB |
| Aug 17, 1990 | K903152 | EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS Syva Co. | DKB |
| Jul 27, 1990 | K902581 | EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) Syva Co. | DKB |
| Jul 10, 1990 | K902578 | EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2 Syva Co. | DKB |
| Jun 6, 1990 | K901573 | EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B Syva Co. | DKB |
| Oct 17, 1989 | K894934 | HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS Hycor Biomedical, Inc. | DKB |
| Jul 25, 1989 | K893815 | HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS Hycor Biomedical, Inc. | DKB |
| May 11, 1989 | K892332 | DRUGS OF ABUSE URINE CALIBRATORS Hycor Biomedical, Inc. | DKB |
| Feb 17, 1989 | K884177 | DRUG STANDARD SET Gelman Sciences, Inc. | DKB |
| Sep 9, 1988 | K881320 | URINE TOXICOLOGY STANDARD Verichem Laboratories, Inc. | DKB |
| Jul 8, 1988 | K881943 | EMIT HVA CALIBRATOR KIT Syva Co. | DKB |
| Jun 22, 1988 | K875216 | HIGH PERFORMANCE CALIBRATORS Rapid Diagnostic Laboratories, Inc. | DKB |
| May 31, 1988 | K880705 | THERAPEUTIC DRUG STANDARD Verichem Laboratories, Inc. | DKB |
| Sep 14, 1987 | K872392 | ACA URINE DRUGS OF ABUSE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | DKB |
| Jun 11, 1987 | K871174 | 4-9295 BARBITURATES TEST MIX Supelco, Inc. | DKB |
| Jul 11, 1986 | K862403 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 Diagnostic Systems | DKB |
| Sep 26, 1984 | K843507 | EMIT 700 CALIBRATOR B Syva Co. | DKB |
| Sep 12, 1984 | K843163 | EMIT 700 CALIBRATOR A Syva Co. | DKB |
| Sep 5, 1984 | K842816 | EMIT D.A.U. LOW & MED. CALIBRATORS B Syva Co. | DKB |
| Aug 15, 1984 | K842386 | ACA BARBITURATES SCREEN/BENZODIAZEPIN E.I. Dupont DE Nemours & Co., Inc. | DKB |
| Feb 3, 1984 | K834398 | LIQUI-SERA TDM CALIBRATORS Biodiagnostic Intl | DKB |
| Jan 13, 1984 | K833761 | THERAPEUTIC DRUG CONTROL Icl Scientific | DKB |
| Jan 1, 1984 | K833276 | DRUG STANDARDS Supelco, Inc. | DKB |
| Jan 5, 1983 | K823740 | ADVANCE SYSTEM EMITAED ANTIEPILEPTIC Syva Co. | DKB |
| Jun 25, 1982 | K821767 | EMIT ST URINE METHAGUALONE CALIBRATOR Syva Co. | DKB |
| Mar 11, 1982 | K820461 | EMIT-ST URINE CALIBRATOR A (#3A319 Syva Co. | DKB |
| Feb 12, 1982 | K820190 | CALIBRATOR SET Syva Co. | DKB |
| Jul 15, 1981 | K811674 | DRUG STANDARDS Supelco, Inc. | DKB |
| Jun 25, 1981 | K811620 | EMIT-TOX SERUM CALIBRATORS Syva Co. | DKB |
| Mar 6, 1981 | K810464 | EMIT-ST SERUM CALBRATOR Syva Co. | DKB |
| Nov 12, 1980 | K802624 | EMIT-STM URINE CALIBRATORS Syva Co. | DKB |
| May 3, 1979 | K790735 | EMIT-TOX SERUM CALIBRATORS Syva Co. | DKB |
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