PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
FDA 510(k) clearance K950028 · decided 1995-03-21
Clearance details
- K-number
- K950028
- Device name
- PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-04
- Decision date
- 1995-03-21
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- LFT
- Device class
- 2
- Regulation number
- 862.3680
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- St. Louis, MO, 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 |
|---|---|---|
| STRATUS PRIMIDONE FLUOROMETRIC ENZYME (K904683) | Baxter Healthcare Corp | 1990-11-28 |
| PRIMIDONE (FPIA) KIT (K895567) | Tudor Laboratories, Inc. | 1989-10-20 |
| COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS (K852318) | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| STRATUS PRIMIDONE FLOROMETRIC ENZY (K842196) | American Dade | 1984-07-11 |
| ADVANCE EMIT-AED PRIMEDONE ASSAY (K823741) | Syva Co. | 1983-01-07 |
| PRIMIDONE FLUORESCENT IMMUNOASSAY (K822229) | American Diagnostic Corp. | 1982-08-12 |
| AMES TDA TM PRIMIDONE TEST (K811007) | Miles Laboratories, Inc. | 1981-04-29 |
Recalls involving this device
No recalls on record reference this clearance.