K122291 is an FDA 510(k) clearance for the THERMO SCIENTIFIC MAS OMNI-CARDIO. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on August 31, 2012, 31 days after receiving the submission on July 31, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K122291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2012 |
| Decision Date | August 31, 2012 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |