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Drug Mixture Control Materials

Regulation 862.3280

0510(k)s in 12 months (202 all time)
0recalls in 12 months (10 all time)
9recalls that name a 510(k)
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Top companies in DIF

Decided510(k)Device and applicantCode
Aug 29, 1984K843161EMIT 700 CONTROL SET A
Syva Co.
DIF
May 16, 1984K841439COMA TOXICOLOGY CONTROL
American Dade
DIF
Apr 5, 1984K840921THERACHEM TDC THERAPEUTIC DRUG CONTROL
Fisher Diagnostics
DIF
Jan 30, 1984K834259LIQUI-URA TOXIC URINE CONTROL
Biodiagnostic Intl
DIF
Jan 24, 1984K833794LYPHOCHEK THERAPEUTIC DRUG CONTROL
Bio-Rad
DIF
Jul 28, 1983K831736TRICYCLIC ANTIDEPRESSANTS
Utak Laboratories, Inc.
DIF
Jul 26, 1983K831741FLURAZEPAM TOXICOLOGY CONTROL
Utak Laboratories, Inc.
DIF
Jul 26, 1983K831734AMOXAPINE 8-HYDRO-XYAMOXAPINE
Utak Laboratories, Inc.
DIF
Jul 19, 1983K831737TRICYCLIC ANTIDEPRESSNATS VI
Utak Laboratories, Inc.
DIF
Jul 6, 1983K831740DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE
Utak Laboratories, Inc.
DIF
Jun 30, 1983K831500TRI-LEVEL TDM CONTROL & I II III
Ortho Diagnostic Systems, Inc.
DIF
May 27, 1983K831278LIQUI-SERA ANTICONVULSANTS CONTROLS
Biodiagnostic Intl
DIF
Apr 5, 1983K830518EMIT-ST PHOTOMETER & DILUTER VERIFICA
Syva Co.
DIF
Mar 11, 1983K830494CONTOX DRUG SCREEN CONTROL
Kaulson Laboratories, Inc.
DIF
Mar 11, 1983K830492CONTOX DURG CONTROL
Kaulson Laboratories, Inc.
DIF
Feb 18, 1983K830234CONTOX HEAVYMETALS CONTROL
Kaulson Laboratories, Inc.
DIF
Jan 12, 1983K823746ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG
Syva Co.
DIF
Oct 8, 1982K822777THERAPEUTIC DRUG CONTROL
Icl Scientific
DIF
Aug 27, 1982K821975ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
Ortho Diagnostic Systems, Inc.
DIF
Jul 20, 1982K821973Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.
Travenol Laboratories, S.A.
DIF
Jul 20, 1982K821950Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
Travenol Laboratories, S.A.
DIF
May 14, 1982K820296STRATUS TDM CONTROL, LEVELS I,II,III
American Dade
DIF
Mar 25, 1982K820468PROFILE GENERAL SET ASSAYED SERUM CONTR
General Diagnostics
DIF
Mar 11, 1982K820462EMIT-ST URINE CONTROLS SET A #3A349
Syva Co.
DIF
Feb 12, 1982K820191CONTROL SET
Syva Co.
DIF
Dec 22, 1981K813349BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
Stanbio Laboratory
DIF
Dec 17, 1981K812950QAC CONTROL
The Quality Assurance Service Corp.
DIF
Jul 15, 1981K811756THERAPEUTIC DRUG CONTROL
Icl Scientific
DIF
Jul 10, 1981K811811TDM ANTI-CONVULSANT CONTROL LEVELS I-II
Environmental Chemical Specialties
DIF
Jul 10, 1981K811809ANTI-ARRHYTHMIC CONTROL LEVELS I & II
Environmental Chemical Specialties
DIF
Jun 25, 1981K811618EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL
Syva Co.
DIF
Mar 11, 1981K810504THERACHEM ANTI CONVULSANTA THEOPHYLLINE
Fisher Scientific Co., LLC
DIF
Mar 6, 1981K810468EMIT-ST SERUM CONTROLS
Syva Co.
DIF
Feb 10, 1981K810235ACETAMINOPHEN/SALICYLATE CONTROL
Clin Tech Diagnostics Corp.
DIF
Feb 2, 1981K810078Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
Hyland Therapeutic Div., Travenol Laboratories
DIF
Jan 28, 1981K810077OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
Hyland Therapeutic Div., Travenol Laboratories
DIF
Dec 22, 1980K803097DIGOXIN & PHENYTOIN CONTROL SERA
Amersham Corp.
DIF
Dec 22, 1980K803039PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.
General Diagnostics
DIF
Dec 22, 1980K803036PROFILE CARDIAC SET ASSAYED SERUM CONTR.
General Diagnostics
DIF
Dec 11, 1980K802854BECKMAN ICS DRUG CONTROL SERA
Beckman Instruments, Inc.
DIF
Nov 24, 1980K802672CARDIOACTIVE DRUGS CONTROL
Fisher Scientific Co., LLC
DIF
Nov 24, 1980K802278IN VITRO DIAGNOSTIC STANDARDS
Supelco, Inc.
DIF
May 2, 1980K800888TRICYCLIC ANTIDEPRESSANTS I TX CONTROL
Utak Laboratories, Inc.
DIF
Apr 29, 1980K800889TRICYCLIC ANTIDEPRESSANT II TX CONTROL
Utak Laboratories, Inc.
DIF
Apr 29, 1980K800887HYPNOTICS PLUS SALICYLATE TX CONTROL
Utak Laboratories, Inc.
DIF
Apr 29, 1980K800886HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL
Utak Laboratories, Inc.
DIF
Apr 29, 1980K800885BARBITURATES TOXICOLOGY CONTROL
Utak Laboratories, Inc.
DIF
Apr 29, 1980K800884CARDIACS II TOXICOLOGY CONTROL
Utak Laboratories, Inc.
DIF
Apr 29, 1980K800883CARDIACS I TOXICOLOGY CONTROL
Utak Laboratories, Inc.
DIF
Apr 29, 1980K800882ANTICONVULSANTS TOXICOLOGY CONTROL
Utak Laboratories, Inc.
DIF

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