Product code DKB
- Device name
- Calibrators, Drug Mixture
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3200
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | Roche Diagnostics Operations (Rdo) | 2014-11-25 |
| K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | Lin-Zhi International, Inc. | 2014-02-21 |
| K120936 | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS | Microgenics Corporation | 2012-12-13 |
| K092266 | RANDOX METHAMPHETAMINE ASSAY | Randox Laboratories, Ltd. | 2011-05-09 |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Microgenics Corp. | 2011-04-08 |
| K090939 | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 | Roche Diagnostics | 2009-06-18 |
| K090900 | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 | Siemens Healthcare Diagnostics | 2009-06-01 |
| K062162 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) | Dade Behring, Inc. | 2006-09-14 |
| K062121 | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) | Dade Behring, Inc. | 2006-08-25 |
| K060645 | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | 2006-05-30 |
| K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2005-06-24 |
| K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | Maine Standards Co. | 2004-02-27 |
| K033306 | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | 2003-12-15 |
| K032574 | DIMENSION DRUG CALIBRATOR II, MODEL DC49C | Dade Behring, Inc. | 2003-10-06 |
| K031856 | PRECISET TDM I AND PRECISET TDM II CALIBRATORS | Roche Diagnostics Corp. | 2003-08-06 |
| K031775 | PRECISET DAT PLUS I CALIBRATORS | Roche Diagnostics Corp. | 2003-08-05 |
| K021393 | PRECISET DAT PLUS | Quantimetrix Corp. | 2002-06-13 |
| K013959 | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS | Bayer Diagnostics Corp. | 2002-01-29 |
| K012318 | RANDOX THERAPEUTIC DRUG CALIBRATOR | Randox Laboratories, Ltd. | 2001-09-12 |
| K993954 | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS | Beckman Coulter, Inc. | 2000-01-11 |
| K993755 | EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 | Syva Co. | 1999-12-21 |
| K990255 | DIMENSION DRUG CALIBRATOR II, MODEL DC49B | Dade Behring, Inc. | 1999-02-16 |
| K983747 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II | Beckman Coulter, Inc. | 1998-12-30 |
| K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | Diagnostic Reagents, Inc. | 1998-11-05 |
| K983209 | SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I | Beckman Coulter, Inc. | 1998-11-04 |
| K982871 | DRUG CALIBRATOR II | Dade Behring, Inc. | 1998-10-13 |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | Beckman Instruments, Inc. | 1998-05-08 |
| K980853 | CEDIA DAU MULTI-DRUG CALIBRATORS | Boehringer Mannheim Corp. | 1998-04-21 |
| K974699 | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE | Consolidated Technologies, Inc. | 1998-01-22 |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | Behring Diagnostics, Inc. | 1997-06-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840937114667 | Immunalysis | IMMUNALYSIS CORP | 2024-04-19 |
| 00840937114650 | Immunalysis | IMMUNALYSIS CORP | 2024-04-19 |
| 00840937114636 | Immunalysis | IMMUNALYSIS CORP | 2024-04-19 |
| 00840937114643 | Immunalysis | IMMUNALYSIS CORP | 2024-04-19 |
| 00613647025291 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2023-06-20 |
| 00840937108901 | Immunalysis | IMMUNALYSIS CORP | 2019-09-16 |
| 00840937108895 | Immunalysis | IMMUNALYSIS CORP | 2019-09-16 |
| 00840937108833 | Immunalysis | IMMUNALYSIS CORP | 2016-10-05 |
| 00842768001789 | Syva® Emit® Calibrator/Control Level 5 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768034169 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 4 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768034152 | Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001765 | Syva® Emit® Calibrator/Control Level 3 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630995158 | CEDIA Antibiotic TDM Multi-Cal | Roche Diagnostics GmbH | 2016-09-23 |
| 04015630996568 | Preciset DAT Plus I | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630996971 | Preciset TDM II | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630996964 | Preciset TDM I | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630996582 | Cfas DAT Qualitiative Plus | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630996575 | Preciset DAT Plus II | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630995172 | CEDIA Core TDM MultiCal | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630994533 | LSD CalibrationControl Pack | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630935048 | ACET2 calibrator | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740081072 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740081935 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00817302020816 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020809 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020793 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST425 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020779 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST325 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00840937104354 | Immunalysis | IMMUNALYSIS CORP | 2016-08-31 |
| 00840937107942 | Immunalysis | IMMUNALYSIS CORP | 2016-08-31 |
| 00840937107959 | Immunalysis | IMMUNALYSIS CORP | 2016-08-31 |