The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Thermo Scientific Mas Omni-core.
| Device ID | K110738 |
| 510k Number | K110738 |
| Device Name: | THERMO SCIENTIFIC MAS OMNI-CORE |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Lisa Charter |
| Correspondent | Lisa Charter Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-17 |
| Decision Date | 2011-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883005433 | K110738 | 000 |
| 00884883005426 | K110738 | 000 |
| 00884883005419 | K110738 | 000 |
| 00884883005402 | K110738 | 000 |