K904683 is an FDA 510(k) clearance for the STRATUS PRIMIDONE FLUOROMETRIC ENZYME. This device is classified as a Fluorescent Immunoassay, Primidone (Class II - Special Controls, product code LFT).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on November 28, 1990, 44 days after receiving the submission on October 15, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K904683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1990 |
| Decision Date | November 28, 1990 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LFT — Fluorescent Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |