Panels › Clinical Toxicology › Product code LBZ · Class 2
Enzyme Immunoassay, Quinidine
Regulation 862.3320
0510(k)s in 12 months (27 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LBZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2005 | K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS Seradyn, Inc. | LBZ |
| Jan 12, 2004 | K032332 | ROCHE ONLINE TDM QUINIDINE Roche Diagnostics Corp. | LBZ |
| Jun 12, 2001 | K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 Syva Co., Dade Behring, Inc. | LBZ |
| Dec 24, 1996 | K964116 | QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | LBZ |
| Dec 18, 1996 | K964212 | QUINIDINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | LBZ |
| Apr 4, 1996 | K955568 | INNOFLUOR QUINIDINE ASSAY SYSTEM Oxis Intl., Inc. | LBZ |
| Jul 6, 1994 | K941440 | COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS Roche Diagnostic Systems, Inc. | LBZ |
| Aug 24, 1992 | K922913 | EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS Syva Co. | LBZ |
| Feb 4, 1991 | K904990 | EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS Syva Co. | LBZ |
| Apr 12, 1990 | K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LBZ |
| Jun 9, 1989 | K892208 | INNOFLUOR(TM) QUINIDINE REAGENT SET Innotron of Oregon, Inc. | LBZ |
| Aug 13, 1987 | K872175 | TDXR FLECAINIDE Abbott Laboratories | LBZ |
| Jan 8, 1987 | K864607 | EASY-TEST QUINIDINE ITEM NO. 67---/95 Em Diagnostic Systems, Inc. | LBZ |
| Jun 27, 1986 | K862214 | EMIT QUINIDINE ASSAY Syva Co. | LBZ |
| Jan 22, 1986 | K860049 | DETERMINATION OF QUINIDINE Clinical Data, Inc. | LBZ |
| Mar 25, 1985 | K850808 | COBAS FP REAGENTS FOR QUINIDINE Roche Diagnostic Systems, Inc. | LBZ |
| Sep 12, 1984 | K843237 | STRATUS QUINIDINE FLUOROMETRIC ENZYME American Dade | LBZ |
| Aug 29, 1984 | K842713 | TDX DISOPYRAMIDE Abbott Laboratories | LBZ |
| Apr 4, 1984 | K840596 | QUINIDINE ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | LBZ |
| Sep 12, 1983 | K832493 | QUINIDINE FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LBZ |
| Aug 8, 1983 | K832096 | EMIT CAD QUINIDINE ASSAY FOR USE W/ Syva Co. | LBZ |
| Jun 30, 1983 | K830963 | QUINIDINE REAGENT TEST KIT Beckman Instruments, Inc. | LBZ |
| Jun 2, 1983 | K831355 | EMIT QST QUINIDINE ASSAY Syva Co. | LBZ |
| Sep 28, 1982 | K822653 | TDX QUINIDINE Abbott Laboratories | LBZ |
| Sep 17, 1982 | K822588 | ADVANCE EMIT-CAD QUINIDINE ASSAY Syva Co. | LBZ |
| Oct 19, 1981 | K812753 | AMES TDA QUINIDINE TEST Miles Laboratories, Inc. | LBZ |
| Jun 9, 1981 | K811460 | EMIT-CAD QUINIDINE ASSAY Syva Co. | LBZ |
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