DIF · Class I · 21 CFR 862.3280

FDA Product Code DIF: Drug Mixture Control Materials

Leading manufacturers include Bio-Rad, Roche Diagnostic Systems, Inc. and Syva Co..

202
Total
202
Cleared
52d
Avg days
1978
Since
202 devices
169–192 of 202
Cleared Apr 29, 1980
CARDIACS I TOXICOLOGY CONTROL
K800883
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
CARDIACS II TOXICOLOGY CONTROL
K800884
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
BARBITURATES TOXICOLOGY CONTROL
K800885
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL
K800886
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
HYPNOTICS PLUS SALICYLATE TX CONTROL
K800887
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
TRICYCLIC ANTIDEPRESSANT II TX CONTROL
K800889
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Mar 02, 1979
THERA CHEM
K782128
Fisher Scientific Co., LLC
Toxicology · 65d
Cleared Dec 07, 1978
SERUM, CONTROL, DRUGS, ANTIARRYTHMIC
K780960
Vitek Systems, Inc.
Toxicology · 178d