DKB — Calibrators, Drug Mixture Class II
FDA product code DKB covers "Calibrators, Drug Mixture", a Class II medical device regulated under 21 CFR 862.3200. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DKB
- Device Class
- Class II
- Regulation Number
- 862.3200
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K141928 | roche diagnostics operations (rdo) | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | November 25, 2014 |
| K133710 | lin-zhi international | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | February 21, 2014 |
| K120936 | microgenics corporation | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT | December 13, 2012 |
| K092266 | randox laboratories | RANDOX METHAMPHETAMINE ASSAY | May 9, 2011 |
| K101752 | microgenics | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | April 8, 2011 |
| K090939 | roche diagnostics | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLIN | June 18, 2009 |
| K090900 | siemens healthcare diagnostics | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 | June 1, 2009 |
| K062162 | dade behring | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) | September 14, 2006 |
| K062121 | dade behring | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) | August 25, 2006 |
| K060645 | roche diagnostics | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRAT | May 30, 2006 |
| K051088 | lin-zhi international | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | June 24, 2005 |
| K033879 | maine standards | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | February 27, 2004 |
| K033306 | roche diagnostics | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | December 15, 2003 |
| K032574 | dade behring | DIMENSION DRUG CALIBRATOR II, MODEL DC49C | October 6, 2003 |
| K031856 | roche diagnostics | PRECISET TDM I AND PRECISET TDM II CALIBRATORS | August 6, 2003 |
| K031775 | roche diagnostics | PRECISET DAT PLUS I CALIBRATORS | August 5, 2003 |
| K021393 | quantimetrix | PRECISET DAT PLUS | June 13, 2002 |
| K013959 | bayer diagnostics | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS | January 29, 2002 |
| K012318 | randox laboratories | RANDOX THERAPEUTIC DRUG CALIBRATOR | September 12, 2001 |
| K993954 | beckman coulter | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS | January 11, 2000 |