K103656 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS R DOA TOTAL. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on March 24, 2011, 99 days after receiving the submission on December 15, 2010.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K103656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2010 |
| Decision Date | March 24, 2011 |
| Days to Decision | 99 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 |