DKB — Calibrators, Drug Mixture Class II
FDA Device Classification
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 |