510(k) K950028
- Device
- PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
- Applicant
- SIGMA DIAGNOSTICS, INC.
- 510(k) number
- K950028
- Product code
- LFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-21
- Date received
- 1995-01-04
- Regulation
- 862.3680
- Classification name
- Fluorescent Immunoassay, Primidone
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOYLE D HILL
- Address
- 545 S. Ewing Ave. St. Louis MO US 63103 63103
FDA Registration Numbers#
- 9610126
Source Documents#
Other 510(k) Records For Product Code LFT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904683 | STRATUS PRIMIDONE FLUOROMETRIC ENZYME | Baxter Healthcare Corp | 1990-11-28 |
| K895567 | PRIMIDONE (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-20 |
| K852318 | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| K842196 | STRATUS PRIMIDONE FLOROMETRIC ENZY | American Dade | 1984-07-11 |
| K823741 | ADVANCE EMIT-AED PRIMEDONE ASSAY | Syva Co. | 1983-01-07 |
| K822229 | PRIMIDONE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-08-12 |
| K811007 | AMES TDA TM PRIMIDONE TEST | Miles Laboratories, Inc. | 1981-04-29 |
Legacy Summary#
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FDA Review#
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