K854607 is an FDA 510(k) clearance for the ACCULEVEL PHENOBARBITAL TEST. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II - Special Controls, product code DLZ).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 25, 1986, 280 days after receiving the submission on November 18, 1985.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K854607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1985 |
| Decision Date | August 25, 1986 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DLZ — Enzyme Immunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |