K935230 is an FDA 510(k) clearance for the EMIT IIC NEGATIVE CONTROL, CONTROL I AND II. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on January 3, 1994, 63 days after receiving the submission on November 1, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K935230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1993 |
| Decision Date | January 03, 1994 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |