LAS · Class I · 21 CFR 862.3280

FDA Product Code LAS: Drug Specific Control Materials

Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and Utak Laboratories, Inc..

83
Total
83
Cleared
61d
Avg days
1976
Since
83 devices
25–48 of 83
Cleared Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Aug 28, 1989
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Aug 21, 1989
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K894463
Roche Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
K893855
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
K893856
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
K893857
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
K893858
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
K893859
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
K893860
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Apr 21, 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004
Bio-Rad
Chemistry · 24d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
K883891
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Oct 29, 1987
QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
K873011
Quantimetrix Medical Industries
Chemistry · 86d
Cleared Jul 07, 1987
DIGOXIN FPIA CONTROLS
K872347
Sigma Diagnostics, Inc.
Toxicology · 20d
Cleared Jul 01, 1987
PHENYTOIN FPIA CONTROLS
K871567
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared May 06, 1987
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
K864456
Cala Diagnostics
Toxicology · 174d
Cleared Nov 13, 1986
BENZODIAZEPINES TOXICOLOGY CONTROL
K862418
Utak Laboratories, Inc.
Toxicology · 141d
Cleared Nov 13, 1986
SERUM VANCOMYCIN TOXICOLOGY CONTROL
K862419
Utak Laboratories, Inc.
Toxicology · 141d
Cleared Nov 05, 1986
SERUM CLONAZEPAM TOXICOLOGY CONTROL
K862421
Utak Laboratories, Inc.
Toxicology · 133d
Cleared Sep 25, 1986
HIGH PERFORMANCE CANNABINOID CONTROLS
K863117
Rapid Diagnostic Laboratories, Inc.
Toxicology · 42d
Cleared Jun 13, 1986
EMIT CAFFEINE CONTROL
K861511
Syva / A Syntex Co.
Toxicology · 51d
Cleared Oct 05, 1984
EMIT 700 CANNABINOID CONTROL SET
K843419
Syva Co.
Toxicology · 35d
Cleared May 11, 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 25d
Cleared Jul 26, 1983
MAPROTILINE
K831735
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
CAFFINE TOXICOLOGY CONTROL
K831738
Utak Laboratories, Inc.
Toxicology · 56d