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 E.I. Dupont DE Nemours & Co., Inc..

83
Total
83
Cleared
61d
Avg days
1976
Since
83 devices
25–48 of 83
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 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 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 May 15, 1979
EMIT GENTAMICIN CONTROL
K790830
Syva Co.
Toxicology · 15d
Cleared Mar 15, 1979
EMIT-QUINIDINE CONTROL
K790402
Syva Co.
Toxicology · 17d
Cleared Jan 10, 1979
EMIT PROCAINAMIDE CONTROL SET
K782084
Syva Co.
Toxicology · 27d
Cleared Jan 03, 1979
CONTROL SET, EMIT METHOTREXATE
K781827
Syva Co.
Toxicology · 65d