K832097 is an FDA 510(k) clearance for the PHENOBARTIAL ASSAY USE ON COBAS-BIO. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II - Special Controls, product code DLZ).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983, 43 days after receiving the submission on June 29, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K832097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1983 |
| Decision Date | August 11, 1983 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DLZ — Enzyme Immunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |