510(k) K942991
- Device
- QMS THEOPHYLLINE CS
- Applicant
- SERADYN, INC.
- 510(k) number
- K942991
- Product code
- LGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-09
- Date received
- 1994-06-20
- Regulation
- 862.3880
- Classification name
- Fluorescence Polarization Immunoassay, Theophylline
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDRIS INDRIKSONS
- Address
- P.O. Box 1210 Indianapolis IN US 46206 46206
FDA Registration Numbers#
- 1219913
- 9610126
- 3006198300
- 9610746
- 3033967997
- 3002809144
- 3003795116
- 8020888
- 3005333358
- 2432235
- 9610529
Source Documents#
Other 510(k) Records For Product Code LGS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070810 | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) | Biokit, S.A. | 2007-06-08 |
| K955567 | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM | Oxis Intl., Inc. | 1996-01-24 |
| K953016 | AXSYM THEOPHYLLINE II | Abbott Laboratories | 1995-08-24 |
| K951169 | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-06-20 |
| K932127 | TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II | Abbott Laboratories | 1993-08-09 |
| K922991 | ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE | Abbott Laboratories | 1992-08-27 |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | Innotron of Oregon, Inc. | 1990-04-12 |
| K894529 | FPR THEOPHYLLINE KIT | Colony Laboratories, Inc. | 1989-09-15 |
| K871484 | COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS | Roche Diagnostic Systems, Inc. | 1987-05-28 |
| K870277 | MONITORX LASERX THEOPHYLLINE REAGENT SET | American Monitor Corp. | 1987-02-18 |
| K850629 | INNOFLUOR THEOPHYLLINE | Innotron Diagnostics | 1985-03-12 |
| K843826 | COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL | Roche Diagnostic Systems, Inc. | 1985-02-01 |
Legacy Summary#
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FDA Review#
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