EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
FDA 510(k) clearance K922913 · decided 1992-08-24
Clearance details
- K-number
- K922913
- Device name
- EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-17
- Decision date
- 1992-08-24
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- LBZ
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, 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 |
| ROCHE ONLINE TDM QUINIDINE (K032332) | Roche Diagnostics Corp. | 2004-01-12 |
| 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 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.