K913429 is an FDA 510(k) clearance for the EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS. This device is classified as a Enzyme Immunoassay, Diphenylhydantoin (Class II - Special Controls, product code DIP).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 26, 1991, 25 days after receiving the submission on August 1, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K913429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1991 |
| Decision Date | August 26, 1991 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DIP — Enzyme Immunoassay, Diphenylhydantoin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |