K910527 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE. This device is classified as a Enzyme Immunoassay, Primidone (Class II - Special Controls, product code DJD).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on March 14, 1991, 35 days after receiving the submission on February 7, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3680.
| 510(k) Number | K910527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1991 |
| Decision Date | March 14, 1991 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJD — Enzyme Immunoassay, Primidone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3680 |