K895567 is an FDA 510(k) clearance for the PRIMIDONE (FPIA) KIT. This device is classified as a Fluorescent Immunoassay, Primidone (Class II - Special Controls, product code LFT).
Submitted by Tudor Laboratories, Inc. (Dallas, US). The FDA issued a Cleared decision on October 20, 1989, 44 days after receiving the submission on September 6, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K895567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1989 |
| Decision Date | October 20, 1989 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LFT — Fluorescent Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |