K953021 is an FDA 510(k) clearance for the ACS PHENOBARBITAL. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on December 11, 1995, 165 days after receiving the submission on June 29, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K953021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1995 |
| Decision Date | December 11, 1995 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |