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
49–72 of 83
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 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
Cleared Dec 07, 1978
THEOPHYLLINE CONTROL SERUM
K780961
Vitek Systems, Inc.
Toxicology · 178d