DLJ — Calibrators, Drug Specific Class II
FDA product code DLJ covers "Calibrators, Drug Specific", 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
- 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 |