DLJ — Calibrators, Drug Specific Class II
FDA Device Classification
Classification Details
- Product Code
- DLJ
- 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 |
|---|
| K132090 | randox laboratories | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPIN | August 8, 2013 |
| K091617 | thermo fisher scientific | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | July 17, 2009 |
| K082030 | siemens healthcare diagnostics | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 | August 22, 2008 |
| K062182 | dade behring | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | September 14, 2006 |
| K062199 | dade behring | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) | September 6, 2006 |
| K061503 | dade behring | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) | June 22, 2006 |
| K060503 | dade behring | DIMENSION TACR CALIBRATOR, MODEL DC107 | May 18, 2006 |
| K053108 | dade behring | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 | February 16, 2006 |
| K052015 | dade behring | DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 | September 12, 2005 |
| K033601 | labone | LABONE MICRO-PLATE COTININE EIA | February 10, 2004 |
| K033246 | roche diagnostics | PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS | December 2, 2003 |
| K033165 | roche diagnostics | PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATO | October 14, 2003 |
| K023780 | microgenics | DRI PRIMIDONE CALIBRATORS | February 10, 2003 |
| K023316 | lin-zhi international | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | December 16, 2002 |
| K021449 | lin-zhi international | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | June 18, 2002 |
| K020845 | dade behring | EMIT 2000 VANCOMYCIN CALIBRATORS | May 8, 2002 |
| K020769 | lin-zhi international | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | April 3, 2002 |
| K012109 | microgenics | DRI ECSTASY URINE CALIBRATORS | August 27, 2001 |
| K011112 | dade behring | CYCLOSPORINE CALIBRATOR | July 17, 2001 |
| K993473 | beckman coulter | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 | November 26, 1999 |