ROCHE ONLINE TDM QUINIDINE
FDA 510(k) clearance K032332 · decided 2004-01-12
Clearance details
- K-number
- K032332
- Device name
- ROCHE ONLINE TDM QUINIDINE
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-29
- Decision date
- 2004-01-12
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- LBZ
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (K052826) | Seradyn, Inc. | 2005-12-23 |
| EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (K011605) | Syva Co., Dade Behring, Inc. | 2001-06-12 |
| QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964116) | Bayer Corp. | 1996-12-24 |
| QUINIDINE ENZYME IMMUNOASSAY (K964212) | Diagnostic Reagents, Inc. | 1996-12-18 |
| INNOFLUOR QUINIDINE ASSAY SYSTEM (K955568) | Oxis Intl., Inc. | 1996-04-04 |
| COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (K941440) | Roche Diagnostic Systems, Inc. | 1994-07-06 |
| EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS (K922913) | Syva Co. | 1992-08-24 |
| EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS (K904990) | Syva Co. | 1991-02-04 |
| MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (K900705) | Innotron of Oregon, Inc. | 1990-04-12 |
| INNOFLUOR(TM) QUINIDINE REAGENT SET (K892208) | Innotron of Oregon, Inc. | 1989-06-09 |
| TDXR FLECAINIDE (K872175) | Abbott Laboratories | 1987-08-13 |
| EASY-TEST QUINIDINE ITEM NO. 67---/95 (K864607) | Em Diagnostic Systems, Inc. | 1987-01-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |