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)
Top companies in DIF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 1991 | K911167 | ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II Analytical Control Systems, Inc. | DIF |
| May 1, 1991 | K910930 | ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 Analytical Control Systems, Inc. | DIF |
| Apr 16, 1991 | K905457 | CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL Consolidated Technologies, Inc. | DIF |
| Apr 12, 1991 | K910333 | CHALLENGE (TM) LIQ THERA DRUG CONTROLS Medical Analysis Systems, Inc. | DIF |
| Dec 11, 1990 | K904905 | DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS Medical Analysis Systems, Inc. | DIF |
| Oct 26, 1990 | K903909 | BLIND CONTROLS FOR DRUGS OF ABUSE TESTING Rapid Diagnostic Laboratories, Inc. | DIF |
| Aug 22, 1990 | K903189 | KODATROL LIQUID CONTROL LEVELS I & II Eastman Kodak Company | DIF |
| May 2, 1990 | K901270 | LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN Bio-Rad | DIF |
| Apr 11, 1990 | K901271 | LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM Bio-Rad | DIF |
| Mar 6, 1990 | K900626 | ALPHA URINE SAMPLE Toxi-Lab, Inc. | DIF |
| Feb 8, 1990 | K892380 | DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III Baxter Healthcare Corp | DIF |
| Dec 7, 1989 | K895816 | BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. Bio-Rad | DIF |
| Sep 28, 1989 | K893682 | KIT- CIBA CORNING L-TDM I, II, III Ciba Corning Diagnostics Corp. | DIF |
| Jul 25, 1989 | K893835 | DAU I, DAU II, DAU III AND DAU IV CONTROL URINE Ciba Corning Diagnostics Corp. | DIF |
| Mar 9, 1989 | K890957 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL: Hycor Biomedical, Inc. | DIF |
| Feb 17, 1989 | K884178 | DRUG CONTROL SET Gelman Sciences, Inc. | DIF |
| Feb 10, 1989 | K890406 | DETECTABUSE DRUG CONTROLS Eastern Laboratories, Ltd. | DIF |
| Jan 23, 1989 | K890030 | NEW LOW LEVEL DRUG MIXTURE CONTROL Rapid Diagnostic Laboratories, Inc. | DIF |
| Sep 19, 1988 | K883210 | EMIT (R) HVA NEGATIVE URINE Syva Co. | DIF |
| Sep 9, 1988 | K883190 | DADE TDM CONTROL Baxter Healthcare Corp | DIF |
| Jul 8, 1988 | K881944 | EMIT HVA CONTROL KIT Syva Co. | DIF |
| Jun 20, 1988 | K881991 | LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE Bio-Rad | DIF |
| Jun 20, 1988 | K881990 | LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW Bio-Rad | DIF |
| Jun 20, 1988 | K881989 | LYPHOCHEK URINE TOXICOLOGY CONTROL Bio-Rad | DIF |
| Jun 20, 1988 | K880145 | LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL Bio-Rad | DIF |
| May 31, 1988 | K880152 | PAR(TM) BRAND DRUG OF ABUSE CONTROLS Medical Analysis Systems, Inc. | DIF |
| Apr 5, 1988 | K880512 | DRUG MIXTURE CONTROL IN URINE Eastern Laboratories, Ltd. | DIF |
| Apr 5, 1988 | K880445 | LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW Bio-Rad | DIF |
| Feb 25, 1988 | K880444 | LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE Bio-Rad | DIF |
| Feb 2, 1988 | K874757 | STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III Baxter Healthcare Corp | DIF |
| Nov 23, 1987 | K873183 | TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS Abbott Laboratories | DIF |
| Oct 7, 1987 | K873539 | ACA URINE DRUGS OF ABUSE CONTROL E.I. Dupont DE Nemours & Co., Inc. | DIF |
| Oct 2, 1987 | K873037 | CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL Diagnostic Products Corp. | DIF |
| Sep 29, 1987 | K873467 | QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL Quantimetrix Medical Industries | DIF |
| Jul 7, 1987 | K871694 | HYPERFORMANCE CONTROLS (HP-CONTROLS) Rapid Diagnostic Laboratories, Inc. | DIF |
| Jun 17, 1987 | K871788 | LIQUID TDM CONTROLS Biological Industries, IL | DIF |
| Apr 1, 1987 | K870586 | TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG Medical Analysis Systems, Inc. | DIF |
| Sep 29, 1986 | K863388 | QUANTIMETRIX DRUG FREE SERUM CONTROL Quantimetrix Corp. | DIF |
| Aug 19, 1986 | K862817 | V-TREND QC TDM CONTROL SERUM 1,2,3. Texas Immunology, Inc. | DIF |
| Aug 19, 1986 | K861970 | LYPHOCHEK URINE TOXICOLOGY CONTROL Bio-Rad | DIF |
| Apr 11, 1986 | K860919 | THERACHEM, TDC THERAPEUTIC DRUG CONTROLS Fisher Scientific Co., LLC | DIF |
| Feb 11, 1986 | K860097 | THERAPEUTIC DRUG (TDM) CALIBRATOR Instrumentation Laboratory CO | DIF |
| Oct 4, 1985 | K853933 | QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL Quantimetrix Corp. | DIF |
| Jul 24, 1985 | K852414 | LYPHOCHEK DRUG FREE SERUM(HUMAN) Bio-Rad | DIF |
| Jan 18, 1985 | K844946 | EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL Syva Co. | DIF |
| Jan 18, 1985 | K844945 | EMIT IMIPRAMINE/DESIPRAMINE CONTROL Syva Co. | DIF |
| Oct 30, 1984 | K843913 | COBAS FP TDM CONTROLS Roche Diagnostic Systems, Inc. | DIF |
| Oct 30, 1984 | K843818 | HUMAN SERUM ANTICONVULSANT DRUG CONTROL Quantimetrix Corp. | DIF |
| Oct 5, 1984 | K843679 | HUMAN SERUM CARDIOACTIVE DRUG CONTROL Quantimetrix Corp. | DIF |
| Sep 28, 1984 | K843508 | EMIT 700 CONTROL SET B Syva Co. | DIF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.