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Panels › Clinical Toxicology › Product code DIF · Class 1

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
May 30, 1997K971691LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
Bio-Rad
DIF
May 21, 1997K971534SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
Beckman
DIF
Apr 8, 1997K971058DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
Medical Analysis Systems, Inc.
DIF
Mar 10, 1997K970666LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
Bio-Rad
DIF
Feb 4, 1997K964771DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
Dyna-Tek Industries
DIF
Jan 17, 1997K965157CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
Boehringer Mannheim Corp.
DIF
Nov 25, 1996K964422ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
Roche Diagnostic Systems, Inc.
DIF
Jun 26, 1996K962165COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
Roche Diagnostic Systems, Inc.
DIF
Jun 3, 1996K961724U-DOA CONTROLS
Medical Diagnostic Technologies, Inc.
DIF
Mar 22, 1996K960244DOCUMENT TDM ULTRA ASSAYED CONTROL
Casco Standards
DIF
Feb 5, 1996K955153LYPHOCHEK BENZO/TCA CONTROL-SET B
Bio-Rad
DIF
Dec 20, 1995K955155DOCUMENT TDM ULTRA UNASSAYED CONTROL
Casco Standards
DIF
Dec 13, 1995K954799ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
Roche Diagnostic Systems, Inc.
DIF
Nov 20, 1995K954291OPUS TDM CONTROLS
Behring Diagnostics, Inc.
DIF
Oct 11, 1995K954322TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
Medical Analysis Systems, Inc.
DIF
Sep 20, 1995K953845ABUSCREEN ONLINE DRUG FREE URINE
Roche Diagnostic Systems, Inc.
DIF
Sep 20, 1995K953739ABUSCREEN ONLINE CONTROLS
Roche Diagnostic Systems, Inc.
DIF
Jun 23, 1995K952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
Dupont Medical Products
DIF
Jun 19, 1995K951817ELI URINE CONTROLS
Elsohly Labs, Inc.
DIF
Jun 1, 1995K952056IMMUNOASSAY DRUGS OF ABUSE CONTROLS
Medi-Tech, Inc.
DIF
Apr 13, 1995K951135MULTI-DRUG CONTROL SET
Microgenics Corp.
DIF
Feb 22, 1995K950138DRUGS OF ABUSE CONTROLS
E.I. Dupont DE Nemours & Co., Inc.
DIF
Jan 25, 1995K943999ABUSCREEN ONTRAK POSITIVE CONTROL
Roche Diagnostic Systems, Inc.
DIF
Dec 9, 1994K945194ABUSCREEN ONLINE CONTROLS
Roche Diagnostic Systems, Inc.
DIF
Nov 2, 1994K943422TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL
Utak Lab, Inc.
DIF
Oct 6, 1994K942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
Medi-Tech, Inc.
DIF
Sep 14, 1994K942257DOA-PLUS, DRUGS OF ABUSE CONTROLS
Medical Diagnostic Technologies, Inc.
DIF
Sep 14, 1994K942041NIDA-5/RT, DRUG OF ABUSE CONTROLS
Meditech
DIF
Sep 9, 1994K942552THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
Medi-Tech, Inc.
DIF
Sep 2, 1994K942114ROCHE TDM CALIBRATION VERIFICATION TEST SET
Roche Diagnostic Systems, Inc.
DIF
Jul 20, 1994K940433DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4
Medical Analysis Systems, Inc.
DIF
Jul 13, 1994K936166CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
Medical Analysis Systems, Inc.
DIF
Jul 6, 1994K934498DOA LIQUID DRUGS OF ABUSE CONTROLS
Medical Analysis Systems, Inc.
DIF
Apr 26, 1994K934650CEDIA DAU CONTROLS
Medical Analysis Systems, Inc.
DIF
Mar 22, 1994K935285DRUGS OF ABUSE CONTROLS
Medical Diagnostic Technologies, Inc.
DIF
Jan 3, 1994K935230EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
Syva Co.
DIF
Dec 29, 1993K934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
Biotrack, Inc.
DIF
Aug 26, 1993K932549ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
Roche Diagnostic Systems, Inc.
DIF
Aug 3, 1993K931125ABUSCREEN ONLINE CONTROL
Roche Diagnostic Systems, Inc.
DIF
Jul 8, 1993K932643LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
Bio-Rad
DIF
Apr 21, 1993K931105PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
Dynagen, Inc.
DIF
Feb 25, 1993K930269COBAS-FP TDM CONTROLS
Roche Diagnostic Systems, Inc.
DIF
Dec 28, 1992K925586DETECTABUSE(TM)
Biochemical Diagnostic, Inc.
DIF
Mar 18, 1992K920477DRUG OF ABUSE URINE CONTROL
Diagnostic Reagents, Inc.
DIF
Nov 22, 1991K914170LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
Bio-Rad
DIF
Nov 19, 1991K914806ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
Roche Diagnostic Systems, Inc.
DIF
Sep 13, 1991K913309TDM I LINEARITY TEST SET
Casco Standards
DIF
Sep 6, 1991K913650DRUG TESTING ASSESSMENT PROGRAM QUALITY CONTROL
Duo Research, Inc.
DIF
May 22, 1991K911724ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
E.I. Dupont DE Nemours & Co., Inc.
DIF
May 1, 1991K911168ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
Analytical Control Systems, Inc.
DIF

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