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
145–168 of 202
Cleared Jan 18, 1985
EMIT IMIPRAMINE/DESIPRAMINE CONTROL
K844945
Syva Co.
Toxicology · 29d
Cleared Jan 18, 1985
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
K844946
Syva Co.
Toxicology · 29d
Cleared Oct 30, 1984
HUMAN SERUM ANTICONVULSANT DRUG CONTROL
K843818
Quantimetrix Corp.
Toxicology · 32d
Cleared Oct 30, 1984
COBAS FP TDM CONTROLS
K843913
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Oct 05, 1984
HUMAN SERUM CARDIOACTIVE DRUG CONTROL
K843679
Quantimetrix Corp.
Chemistry · 17d
Cleared Sep 28, 1984
EMIT 700 CONTROL SET B
K843508
Syva Co.
Toxicology · 22d
Cleared Aug 29, 1984
EMIT 700 CONTROL SET A
K843161
Syva Co.
Toxicology · 19d
Cleared May 16, 1984
COMA TOXICOLOGY CONTROL
K841439
American Dade
Toxicology · 40d
Cleared Apr 05, 1984
THERACHEM TDC THERAPEUTIC DRUG CONTROL
K840921
Fisher Diagnostics
Toxicology · 34d
Cleared Jan 30, 1984
LIQUI-URA TOXIC URINE CONTROL
K834259
Biodiagnostic Intl
Toxicology · 54d
Cleared Jan 24, 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794
Bio-Rad
Chemistry · 84d
Cleared Jul 28, 1983
TRICYCLIC ANTIDEPRESSANTS
K831736
Utak Laboratories, Inc.
Toxicology · 58d
Cleared Jul 26, 1983
AMOXAPINE 8-HYDRO-XYAMOXAPINE
K831734
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
FLURAZEPAM TOXICOLOGY CONTROL
K831741
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 19, 1983
TRICYCLIC ANTIDEPRESSNATS VI
K831737
Utak Laboratories, Inc.
Toxicology · 49d
Cleared Jul 06, 1983
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE
K831740
Utak Laboratories, Inc.
Toxicology · 36d
Cleared Jun 30, 1983
TRI-LEVEL TDM CONTROL & I II III
K831500
Ortho Diagnostic Systems, Inc.
Toxicology · 50d
Cleared May 27, 1983
LIQUI-SERA ANTICONVULSANTS CONTROLS
K831278
Biodiagnostic Intl
Toxicology · 38d
Cleared Apr 05, 1983
EMIT-ST PHOTOMETER & DILUTER VERIFICA
K830518
Syva Co.
Toxicology · 47d
Cleared Mar 11, 1983
CONTOX DURG CONTROL
K830492
Kaulson Laboratories, Inc.
Toxicology · 23d
Cleared Mar 11, 1983
CONTOX DRUG SCREEN CONTROL
K830494
Kaulson Laboratories, Inc.
Toxicology · 23d
Cleared Feb 18, 1983
CONTOX HEAVYMETALS CONTROL
K830234
Kaulson Laboratories, Inc.
Toxicology · 24d
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