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
49–72 of 202
Cleared Sep 09, 1988
DADE TDM CONTROL
K883190
Baxter Healthcare Corp
Pathology · 43d
Cleared Jul 08, 1988
EMIT HVA CONTROL KIT
K881944
Syva Co.
Toxicology · 60d
Cleared Jun 20, 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145
Bio-Rad
Toxicology · 159d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K881990
Bio-Rad
Toxicology · 39d
Cleared Jun 20, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991
Bio-Rad
Toxicology · 39d
Cleared Apr 05, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445
Bio-Rad
Toxicology · 63d
Cleared Feb 25, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K880444
Bio-Rad
Toxicology · 23d
Cleared Feb 02, 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757
Baxter Healthcare Corp
Toxicology · 76d
Cleared Nov 23, 1987
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183
Abbott Laboratories
Toxicology · 103d
Cleared Oct 07, 1987
ACA URINE DRUGS OF ABUSE CONTROL
K873539
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Oct 02, 1987
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL
K873037
Diagnostic Products Corp.
Toxicology · 59d
Cleared Aug 19, 1986
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970
Bio-Rad
Toxicology · 90d
Cleared Feb 11, 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097
Instrumentation Laboratory CO
Toxicology · 32d
Cleared Jul 24, 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414
Bio-Rad
Toxicology · 48d
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
COBAS FP TDM CONTROLS
K843913
Roche Diagnostic Systems, Inc.
Toxicology · 26d
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 Jan 24, 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794
Bio-Rad
Chemistry · 84d
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 Mar 11, 1982
EMIT-ST URINE CONTROLS SET A #3A349
K820462
Syva Co.
Toxicology · 20d