K897114 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY. This device is classified as a Enzyme Immunoassay, Carbamazepine (Class II - Special Controls, product code KLT).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on January 18, 1990, 23 days after receiving the submission on December 26, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K897114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1989 |
| Decision Date | January 18, 1990 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KLT — Enzyme Immunoassay, Carbamazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |