K823746 is an FDA 510(k) clearance for the ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1983, 30 days after receiving the submission on December 13, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K823746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1982 |
| Decision Date | January 12, 1983 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |