K011347 is an FDA 510(k) clearance for the EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229. This device is classified as a Enzyme Immunoassay, Diphenylhydantoin (Class II - Special Controls, product code DIP).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on May 17, 2001, 15 days after receiving the submission on May 2, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K011347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2001 |
| Decision Date | May 17, 2001 |
| Days to Decision | 15 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIP — Enzyme Immunoassay, Diphenylhydantoin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |