LBZ — Enzyme Immunoassay, Quinidine Class II
FDA product code LBZ covers "Enzyme Immunoassay, Quinidine", a Class II medical device regulated under 21 CFR 862.3320. 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
- LBZ
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052826 | seradyn | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | December 23, 2005 |
| K032332 | roche diagnostics | ROCHE ONLINE TDM QUINIDINE | January 12, 2004 |
| K011605 | syva co., dade behring | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 | June 12, 2001 |
| K964116 | bayer | QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | December 24, 1996 |
| K964212 | diagnostic reagents | QUINIDINE ENZYME IMMUNOASSAY | December 18, 1996 |
| K955568 | oxis intl | INNOFLUOR QUINIDINE ASSAY SYSTEM | April 4, 1996 |
| K941440 | roche diagnostic systems | COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS | July 6, 1994 |
| K922913 | syva | EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS | August 24, 1992 |
| K904990 | syva | EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS | February 4, 1991 |
| K900705 | innotron of oregon | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | April 12, 1990 |
| K892208 | innotron of oregon | INNOFLUOR(TM) QUINIDINE REAGENT SET | June 9, 1989 |
| K872175 | abbott laboratories | TDXR FLECAINIDE | August 13, 1987 |
| K864607 | em diagnostic systems | EASY-TEST QUINIDINE ITEM NO. 67---/95 | January 8, 1987 |
| K862214 | syva | EMIT QUINIDINE ASSAY | June 27, 1986 |
| K860049 | clinical data | DETERMINATION OF QUINIDINE | January 22, 1986 |
| K850808 | roche diagnostic systems | COBAS FP REAGENTS FOR QUINIDINE | March 25, 1985 |
| K843237 | american dade | STRATUS QUINIDINE FLUOROMETRIC ENZYME | September 12, 1984 |
| K842713 | abbott laboratories | TDX DISOPYRAMIDE | August 29, 1984 |
| K840596 | e.i. dupont de nemours and co | QUINIDINE ANALYTICAL TEST PACK | April 4, 1984 |
| K832493 | american diagnostic | QUINIDINE FLUORESCENT IMMUNOASSAY | September 12, 1983 |