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 Medical Analysis Systems, Inc..

202
Total
202
Cleared
52d
Avg days
1978
Since
202 devices
121–144 of 202
Cleared May 16, 1984
COMA TOXICOLOGY CONTROL
K841439
American Dade
Toxicology · 40d
Cleared Jan 24, 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794
Bio-Rad
Chemistry · 84d
Cleared Jun 30, 1983
TRI-LEVEL TDM CONTROL & I II III
K831500
Ortho Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Apr 05, 1983
EMIT-ST PHOTOMETER & DILUTER VERIFICA
K830518
Syva Co.
Toxicology · 47d
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