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
49–72 of 83
Cleared Jul 19, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
K831979
Syva Co.
Toxicology · 29d
Cleared Jul 06, 1983
PENTOBARBITAL TOXICOLOGY CONTROL
K831739
Utak Laboratories, Inc.
Toxicology · 36d
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
Cleared Feb 04, 1981
TOXICOLOGY CONTROL
K810201
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Dec 22, 1980
AMES TDA AMIKACIN CONTROL SERUM
K803107
Miles Laboratories, Inc.
Chemistry · 12d
Cleared Jun 17, 1980
EMIT VALPROIC ACID CONTROL
K801206
Syva Co.
Toxicology · 29d
Cleared Jun 09, 1980
EMIT DISOPYRAMIDE CONTROL
K801205
Syva Co.
Toxicology · 21d
Cleared Apr 16, 1980
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
K800357
Ortho Diagnostics, Inc.
Toxicology · 56d
Cleared Dec 18, 1979
AMIKACIN CONTROL SERUM
K792259
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
AMIKACIN LIQUID CONTROL SERUM
K792260
Hemometrix
Toxicology · 39d