K860048 is an FDA 510(k) clearance for the DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN). This device is classified as a Enzyme Immunoassay, Diphenylhydantoin (Class II - Special Controls, product code DIP).
Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on January 22, 1986, 16 days after receiving the submission on January 6, 1986.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K860048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1986 |
| Decision Date | January 22, 1986 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DIP — Enzyme Immunoassay, Diphenylhydantoin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |