510(k) K052826
- Device
- QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
- Applicant
- SERADYN INC.
- 510(k) number
- K052826
- Product code
- LBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-23
- Date received
- 2005-10-05
- Regulation
- 862.3320
- Classification name
- Enzyme Immunoassay, Quinidine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK ROGERS
- Address
- 7998 Georgetown Rd. Suite 1000 Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 9610529
- 3010939897
- 2517506
- 9610126
- 3005333358
- 3006198300
- 3003795116
Source Documents#
Other 510(k) Records For Product Code LBZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
summary
FDA Review#
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