Panels › Clinical Toxicology › Product code DKB · Class 2
Calibrators, Drug Mixture
Regulation 862.3200
0510(k)s in 12 months (94 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in DKB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 2014 | K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR Roche Diagnostics Operations (Rdo) | DKB |
| Feb 21, 2014 | K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS Lin-Zhi International, Inc. | DKB |
| Dec 13, 2012 | K120936 | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS Microgenics Corporation | DKB |
| May 9, 2011 | K092266 | RANDOX METHAMPHETAMINE ASSAY Randox Laboratories, Ltd., GB | DKB |
| Apr 8, 2011 | K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS Microgenics Corp. | DKB |
| Jun 18, 2009 | K090939 | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 Roche Diagnostics | DKB |
| Jun 1, 2009 | K090900 | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 Siemens Healthcare Diagnostics | DKB |
| Sep 14, 2006 | K062162 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) Dade Behring, Inc. | DKB |
| Aug 25, 2006 | K062121 | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) Dade Behring, Inc. | DKB |
| May 30, 2006 | K060645 | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS Roche Diagnostics Corp. | DKB |
| Jun 24, 2005 | K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DKB |
| Feb 27, 2004 | K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 Maine Standards Co. | DKB |
| Dec 15, 2003 | K033306 | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS Roche Diagnostics Corp. | DKB |
| Oct 6, 2003 | K032574 | DIMENSION DRUG CALIBRATOR II, MODEL DC49C Dade Behring, Inc. | DKB |
| Aug 6, 2003 | K031856 | PRECISET TDM I AND PRECISET TDM II CALIBRATORS Roche Diagnostics Corp. | DKB |
| Aug 5, 2003 | K031775 | PRECISET DAT PLUS I CALIBRATORS Roche Diagnostics Corp. | DKB |
| Jun 13, 2002 | K021393 | PRECISET DAT PLUS Quantimetrix Corp. | DKB |
| Jan 29, 2002 | K013959 | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS Bayer Diagnostics Corp. | DKB |
| Sep 12, 2001 | K012318 | RANDOX THERAPEUTIC DRUG CALIBRATOR Randox Laboratories, Ltd., GB | DKB |
| Jan 11, 2000 | K993954 | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS Beckman Coulter, Inc. | DKB |
| Dec 21, 1999 | K993755 | EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 Syva Co. | DKB |
| Feb 16, 1999 | K990255 | DIMENSION DRUG CALIBRATOR II, MODEL DC49B Dade Behring, Inc. | DKB |
| Dec 30, 1998 | K983747 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II Beckman Coulter, Inc. | DKB |
| Nov 5, 1998 | K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS Diagnostic Reagents, Inc. | DKB |
| Nov 4, 1998 | K983209 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I Beckman Coulter, Inc. | DKB |
| Oct 13, 1998 | K982871 | DRUG CALIBRATOR II Dade Behring, Inc. | DKB |
| May 8, 1998 | K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT Beckman Instruments, Inc. | DKB |
| Apr 21, 1998 | K980853 | CEDIA DAU MULTI-DRUG CALIBRATORS Boehringer Mannheim Corp. | DKB |
| Jan 22, 1998 | K974699 | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE Consolidated Technologies, Inc. | DKB |
| Jun 25, 1997 | K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) Behring Diagnostics, Inc. | DKB |
| May 8, 1997 | K971287 | SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS Beckman Instruments, Inc. | DKB |
| Sep 16, 1996 | K962817 | DRUG CALIBRATOR II Dade Intl., Inc. | DKB |
| Sep 10, 1996 | K963191 | CEDIA ANTIBIOTIC TDM MULTI-CALS Boehringer Mannheim Corp. | DKB |
| May 15, 1996 | K961273 | AED CALIBRATORS Diagnostic Reagents, Inc. | DKB |
| May 1, 1996 | K961372 | SERUM TOX CALIBRATOR Diagnostic Reagents, Inc. | DKB |
| Dec 26, 1995 | K954608 | CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH Boehringer Mannheim Corp. | DKB |
| Mar 24, 1995 | K935192 | EMIT IIC CALIBRATORS Syva Co. | DKB |
| Feb 22, 1995 | K950139 | DRUGS OF ABUSE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | DKB |
| Dec 13, 1994 | K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR Medi-Tech, Inc. | DKB |
| Oct 4, 1994 | K942048 | ROCHE AMMONIA (VARIOUS) Roche Diagnostic Systems, Inc. | DKB |
| Jul 6, 1994 | K940935 | URINE CALIBRATOR Diagnostic Reagents, Inc. | DKB |
| Mar 14, 1994 | K936028 | CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB Microgenics Corp. | DKB |
| Mar 14, 1994 | K935793 | CEDIA DAU NEGATIVE CALIBRATOR Microgenics Corp. | DKB |
| Jan 27, 1994 | K935101 | URINE CALIBRATORS AND CONTROLS MODIFICATION Diagnostic Reagents, Inc. | DKB |
| Jan 25, 1994 | K935794 | CEDIA DAU 4-DRUG CUTOFF CALIBRATOR Microgenics Corp. | DKB |
| Jan 25, 1994 | K935792 | CEDIA DAU 5-DRUG CALIBRATORS Microgenics Corp. | DKB |
| Jan 3, 1994 | K935550 | ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK Roche Diagnostic Systems, Inc. | DKB |
| Aug 3, 1993 | K931124 | ABUSCREEN ONLINE(R) CALIBRATORS Roche Diagnostic Systems, Inc. | DKB |
| Jul 22, 1993 | K932754 | ABUSCREEN CALIBRATION STANDARD Roche Diagnostic Systems, Inc. | DKB |
| Jul 22, 1993 | K932753 | ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS Roche Diagnostic Systems, Inc. | DKB |
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