K832720 is an FDA 510(k) clearance for the EMIT AED CARBAMAZEPINE ASSAY. This device is classified as a Enzyme Immunoassay, Carbamazepine (Class II - Special Controls, product code KLT).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983, 53 days after receiving the submission on August 12, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K832720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1983 |
| Decision Date | October 04, 1983 |
| Days to Decision | 53 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 |