K011528 is an FDA 510(k) clearance for the EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II - Special Controls, product code DLZ).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on June 6, 2001, 20 days after receiving the submission on May 17, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K011528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2001 |
| Decision Date | June 06, 2001 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DLZ — Enzyme Immunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |