K950028 is an FDA 510(k) clearance for the PRIMIDONE FPIA REAGENT SET AND CALIBRATORS. This device is classified as a Fluorescent Immunoassay, Primidone (Class II - Special Controls, product code LFT).
Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 21, 1995, 76 days after receiving the submission on January 4, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K950028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 1995 |
| Decision Date | March 21, 1995 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LFT — Fluorescent Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |