K080085 is an FDA 510(k) clearance for the MAS TOX CONTROL. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Thermo Fisher Scientific (Fremont Blvd., US). The FDA issued a Cleared decision on April 30, 2008, 110 days after receiving the submission on January 11, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K080085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2008 |
| Decision Date | April 30, 2008 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |