K896074 is an FDA 510(k) clearance for the VISION PHENYTOIN. This device is classified as a Enzyme Immunoassay, Diphenylhydantoin (Class II - Special Controls, product code DIP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 17, 1989, 29 days after receiving the submission on October 19, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K896074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1989 |
| Decision Date | November 17, 1989 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DIP — Enzyme Immunoassay, Diphenylhydantoin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |