Product code LBZ
- Device name
- Enzyme Immunoassay, Quinidine
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3320
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | Seradyn, Inc. | 2005-12-23 |
| K032332 | ROCHE ONLINE TDM QUINIDINE | Roche Diagnostics Corp. | 2004-01-12 |
| K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 | Syva Co., Dade Behring, Inc. | 2001-06-12 |
| K964116 | QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1996-12-24 |
| K964212 | QUINIDINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1996-12-18 |
| K955568 | INNOFLUOR QUINIDINE ASSAY SYSTEM | Oxis Intl., Inc. | 1996-04-04 |
| K941440 | COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS | Roche Diagnostic Systems, Inc. | 1994-07-06 |
| K922913 | EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS | Syva Co. | 1992-08-24 |
| K904990 | EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS | Syva Co. | 1991-02-04 |
| K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-12 |
| K892208 | INNOFLUOR(TM) QUINIDINE REAGENT SET | Innotron of Oregon, Inc. | 1989-06-09 |
| K872175 | TDXR FLECAINIDE | Abbott Laboratories | 1987-08-13 |
| K864607 | EASY-TEST QUINIDINE ITEM NO. 67---/95 | Em Diagnostic Systems, Inc. | 1987-01-08 |
| K862214 | EMIT QUINIDINE ASSAY | Syva Co. | 1986-06-27 |
| K860049 | DETERMINATION OF QUINIDINE | Clinical Data, Inc. | 1986-01-22 |
| K850808 | COBAS FP REAGENTS FOR QUINIDINE | Roche Diagnostic Systems, Inc. | 1985-03-25 |
| K843237 | STRATUS QUINIDINE FLUOROMETRIC ENZYME | American Dade | 1984-09-12 |
| K842713 | TDX DISOPYRAMIDE | Abbott Laboratories | 1984-08-29 |
| K840596 | QUINIDINE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1984-04-04 |
| K832493 | QUINIDINE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1983-09-12 |
| K832096 | EMIT CAD QUINIDINE ASSAY FOR USE W/ | Syva Co. | 1983-08-08 |
| K830963 | QUINIDINE REAGENT TEST KIT | Beckman Instruments, Inc. | 1983-06-30 |
| K831355 | EMIT QST QUINIDINE ASSAY | Syva Co. | 1983-06-02 |
| K822653 | TDX QUINIDINE | Abbott Laboratories | 1982-09-28 |
| K822588 | ADVANCE EMIT-CAD QUINIDINE ASSAY | Syva Co. | 1982-09-17 |
| K812753 | AMES TDA QUINIDINE TEST | Miles Laboratories, Inc. | 1981-10-19 |
| K811460 | EMIT-CAD QUINIDINE ASSAY | Syva Co. | 1981-06-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336147917 | ONLINE TDM Quinidine | Roche Diagnostics GmbH | 2021-01-15 |
| 00884883005990 | QMS Quinidine Immunoassay | Microgenics Corporation | 2016-09-26 |
| 00842768001048 | Syva® Emit® 2000 Qunidine Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001055 | Syva® Emit® 2000 Quinidine Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023293 | Emit® 2000 Quinidine Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883006003 | QMS Quinidine Immunoassay Calibrator Set | Microgenics Corporation | 2016-09-22 |
| 04015630999262 | Quinidine | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630915873 | Quinidine | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740011215 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740011222 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |