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
73–83 of 83
Cleared Dec 18, 1979
GENTAMICIN CONTROL SERUM
K792261
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
GENTAMICIN LIQUID CONTROL SERUM
K792262
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
TOBRAMYCIN CONTROL SERUM
K792263
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
TOBRAMYCIN LIQUID CONTROL SERUM
K792264
Hemometrix
Toxicology · 39d
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
Cleared Feb 03, 1978
ANTICONVULSANT CONTROL SERUM
K780142
Mcdonnell Douglas Corp.
Toxicology · 8d
Cleared Oct 07, 1976
ANTICONVULSANT CONTROL SERUM
K760730
Bio-Reagents & Diagnostics, Inc.
Toxicology · 10d