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 Microgenics Corp..

83
Total
83
Cleared
61d
Avg days
1976
Since
83 devices
25–48 of 83
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 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 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 19, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
K831979
Syva Co.
Toxicology · 29d
Cleared Jun 16, 1983
EMIT QST TOBRAMYCIN CONTROL
K831417
Syva Co.
Toxicology · 44d
Cleared Jan 28, 1983
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL
K830049
Syva Co.
Chemistry · 18d
Cleared Dec 15, 1982
ADVANCE EMIT(R) & TM AMIKACIN CONTROL
K823369
Syva Co.
Toxicology · 35d
Cleared Oct 27, 1982
SYVA ADVANCE EMIT AED VALPROIC ACID CONT
K822934
Syva Co.
Toxicology · 23d
Cleared Jun 24, 1982
EMIT - ST URINE METHAGUALONE CONTROLS
K821766
Syva Co.
Toxicology · 9d
Cleared Jun 02, 1982
EMIT TOX ACETAMINOPHEN CONTROL
K821380
Syva Co.
Toxicology · 23d
Cleared Mar 11, 1982
EMIT-AMD AMIKACIN CONTROL
K820439
Syva Co.
Toxicology · 22d
Cleared Mar 04, 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
K820392
Ortho Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Feb 23, 1982
SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL
K820286
Syva Co.
Toxicology · 21d
Cleared Feb 23, 1982
EMIT AND NETILMICIN CONTROL
K820323
Syva Co.
Toxicology · 18d
Cleared Jan 29, 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL
K820129
Syva Co.
Toxicology · 11d
Cleared Dec 03, 1981
EMIT-AAD THEOPHYLLINE CONTROL
K813241
Syva Co.
Toxicology · 16d
Cleared Aug 20, 1981
EMIT-ST CANNABINOID CONTROLS
K812196
Syva Co.
Toxicology · 17d
Cleared Jun 25, 1981
EMIT-ST SERUM PHENOBARBITAL CONTROLS
K811619
Syva Co.
Toxicology · 17d
Cleared Jun 09, 1981
EMIT-CAD QUINDINE CONTROL
K811462
Syva Co.
Toxicology · 14d