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
145–168 of 202
Cleared Jan 12, 1983
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG
K823746
Syva Co.
Chemistry · 30d
Cleared Oct 08, 1982
THERAPEUTIC DRUG CONTROL
K822777
Icl Scientific
Toxicology · 24d
Cleared Aug 27, 1982
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
K821975
Ortho Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Jul 20, 1982
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
K821950
Travenol Laboratories, S.A.
Toxicology · 20d
Cleared Jul 20, 1982
Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.
K821973
Travenol Laboratories, S.A.
Toxicology · 18d
Cleared May 14, 1982
STRATUS TDM CONTROL, LEVELS I,II,III
K820296
American Dade
Chemistry · 99d
Cleared Mar 25, 1982
PROFILE GENERAL SET ASSAYED SERUM CONTR
K820468
General Diagnostics
Toxicology · 31d
Cleared Mar 11, 1982
EMIT-ST URINE CONTROLS SET A #3A349
K820462
Syva Co.
Toxicology · 20d
Cleared Feb 12, 1982
CONTROL SET
K820191
Syva Co.
Toxicology · 18d
Cleared Dec 22, 1981
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349
Stanbio Laboratory
Microbiology · 25d
Cleared Jul 15, 1981
THERAPEUTIC DRUG CONTROL
K811756
Icl Scientific
Toxicology · 23d
Cleared Jun 25, 1981
EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL
K811618
Syva Co.
Toxicology · 17d
Cleared Mar 11, 1981
THERACHEM ANTI CONVULSANTA THEOPHYLLINE
K810504
Fisher Scientific Co., LLC
Toxicology · 15d
Cleared Mar 06, 1981
EMIT-ST SERUM CONTROLS
K810468
Syva Co.
Toxicology · 11d
Cleared Feb 02, 1981
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
K810078
Hyland Therapeutic Div., Travenol Laboratories
Chemistry · 20d
Cleared Jan 28, 1981
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
K810077
Hyland Therapeutic Div., Travenol Laboratories
Chemistry · 15d
Cleared Dec 22, 1980
PROFILE CARDIAC SET ASSAYED SERUM CONTR.
K803036
General Diagnostics
Toxicology · 21d
Cleared Dec 22, 1980
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.
K803039
General Diagnostics
Toxicology · 21d
Cleared Dec 22, 1980
DIGOXIN & PHENYTOIN CONTROL SERA
K803097
Amersham Corp.
Toxicology · 14d
Cleared Dec 11, 1980
BECKMAN ICS DRUG CONTROL SERA
K802854
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Nov 24, 1980
IN VITRO DIAGNOSTIC STANDARDS
K802278
Supelco, Inc.
Toxicology · 73d
Cleared Nov 24, 1980
CARDIOACTIVE DRUGS CONTROL
K802672
Fisher Scientific Co., LLC
Toxicology · 28d
Cleared May 02, 1980
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL
K800888
Utak Laboratories, Inc.
Toxicology · 15d
Cleared Apr 29, 1980
ANTICONVULSANTS TOXICOLOGY CONTROL
K800882
Utak Laboratories, Inc.
Toxicology · 12d