Panels › Clinical Toxicology › Product code LAS · Class 1
Drug Specific Control Materials
Regulation 862.3280
0510(k)s in 12 months (83 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LAS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 2009 | K080459 | CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS Chromsystems Instruments & Chemicals GmbH | LAS |
| Jan 30, 2008 | K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL More Diagnostics | LAS |
| Oct 30, 2006 | K062942 | QUANTIMETRIX NICOSURE COTININE URINE CONTROL Quantimetrix Corp. | LAS |
| Jun 6, 2005 | K051074 | MAS IMMUNOSUPPRESSANT CONTROLS Microgenics Corp. | LAS |
| May 27, 2004 | K040411 | DRI OXYCODONE ASSAY Microgenics Corp. | LAS |
| Oct 17, 2003 | K032842 | MICROGENICS CYCLOSPORINE CONTROL KIT Microgenics Corp. | LAS |
| Mar 31, 2003 | K030616 | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 Microgenics Corp. | LAS |
| Jul 14, 1999 | K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE Consolidated Technologies, Inc. | LAS |
| May 12, 1997 | K970517 | INNOFLUOR TOPIRAMATE CONTROL SET Oxis Intl., Inc. | LAS |
| Apr 17, 1997 | K971210 | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS Beckman Instruments, Inc. | LAS |
| Feb 7, 1995 | K946119 | ROCHE-TDM ONLEIN(TM) CONTROLS Roche Diagnostic Systems, Inc. | LAS |
| Aug 24, 1994 | K943048 | MICROGENICS THC CONTROL SETS Microgenics Corp. | LAS |
| Jan 27, 1994 | K930844 | ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE Roche Diagnostic Systems, Inc. | LAS |
| Nov 9, 1993 | K934145 | DUPONT ACA URINE METHADONE CONTROL E.I. Dupont DE Nemours & Co., Inc. | LAS |
| Sep 10, 1993 | K933557 | REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE Consolidated Technologies, Inc. | LAS |
| Jul 26, 1993 | K932662 | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL More Diagnostics | LAS |
| Jul 16, 1992 | K921939 | SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) Heraeus Kulzer, Inc. | LAS |
| Apr 17, 1992 | K921141 | CANNABINOID URINE CONTROLS Diagnostic Reagents, Inc. | LAS |
| Jan 28, 1992 | K915516 | ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL Roche Diagnostic Systems, Inc. | LAS |
| Sep 25, 1991 | K913677 | ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III Analytical Control Systems, Inc. | LAS |
| Aug 26, 1991 | K913336 | ABUSCREEN(R) ONLINE(TM) CONTROLS Roche Diagnostic Systems, Inc. | LAS |
| Aug 12, 1991 | K913107 | ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ Roche Diagnostic Systems, Inc. | LAS |
| Apr 12, 1991 | K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Apr 3, 1991 | K910829 | LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 Bio-Rad | LAS |
| Mar 11, 1991 | K910689 | ABUSCREEN(R) ONLINE CONTROLS Roche Diagnostic Systems, Inc. | LAS |
| Aug 28, 1989 | K894464 | ABUSCREEN POSITIVE REFERENCE CONTROLS Roche Diagnostic Systems, Inc. | LAS |
| Aug 21, 1989 | K894463 | ABUSCREEN TRI-LEVEL REFERENCE CONTROLS Roche Diagnostic Systems, Inc. | LAS |
| Aug 3, 1989 | K893860 | ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE Roche Diagnostic Systems, Inc. | LAS |
| Aug 3, 1989 | K893859 | ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE Roche Diagnostic Systems, Inc. | LAS |
| Aug 3, 1989 | K893858 | ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC Roche Diagnostic Systems, Inc. | LAS |
| Aug 3, 1989 | K893857 | ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE Roche Diagnostic Systems, Inc. | LAS |
| Aug 3, 1989 | K893856 | ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE Roche Diagnostic Systems, Inc. | LAS |
| Aug 3, 1989 | K893855 | ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES Roche Diagnostic Systems, Inc. | LAS |
| Apr 21, 1989 | K892004 | LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3 Bio-Rad | LAS |
| Nov 29, 1988 | K883891 | DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER E.I. Dupont DE Nemours & Co., Inc. | LAS |
| Oct 29, 1987 | K873011 | QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 Quantimetrix Medical Industries | LAS |
| Jul 7, 1987 | K872347 | DIGOXIN FPIA CONTROLS Sigma Diagnostics, Inc. | LAS |
| Jul 1, 1987 | K871567 | PHENYTOIN FPIA CONTROLS Sigma Diagnostics, Inc. | LAS |
| May 6, 1987 | K864456 | CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 Cala Diagnostics | LAS |
| Nov 13, 1986 | K862419 | SERUM VANCOMYCIN TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Nov 13, 1986 | K862418 | BENZODIAZEPINES TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Nov 5, 1986 | K862421 | SERUM CLONAZEPAM TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Sep 25, 1986 | K863117 | HIGH PERFORMANCE CANNABINOID CONTROLS Rapid Diagnostic Laboratories, Inc. | LAS |
| Jun 13, 1986 | K861511 | EMIT CAFFEINE CONTROL Syva / A Syntex Co. | LAS |
| Oct 5, 1984 | K843419 | EMIT 700 CANNABINOID CONTROL SET Syva Co. | LAS |
| May 11, 1984 | K841533 | ACA TRICYCLIC ANTIDEPRESSANTS SCREEN E.I. Dupont DE Nemours & Co., Inc. | LAS |
| Jul 26, 1983 | K831738 | CAFFINE TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
| Jul 26, 1983 | K831735 | MAPROTILINE Utak Laboratories, Inc. | LAS |
| Jul 19, 1983 | K831979 | EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO Syva Co. | LAS |
| Jul 6, 1983 | K831739 | PENTOBARBITAL TOXICOLOGY CONTROL Utak Laboratories, Inc. | LAS |
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