The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Mas Omni-immune, Mas Omni Immune Pro.
| Device ID | K110616 |
| 510k Number | K110616 |
| Device Name: | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Contact | Lisa Charter |
| Correspondent | Lisa Charter MICROGENICS CORP. 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 | 2011-03-03 |
| Decision Date | 2011-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883005396 | K110616 | 000 |
| 00884883005389 | K110616 | 000 |
| 00884883005372 | K110616 | 000 |
| 00884883005365 | K110616 | 000 |
| 00884883005358 | K110616 | 000 |
| 00884883005341 | K110616 | 000 |
| 00884883005334 | K110616 | 000 |
| 00884883005327 | K110616 | 000 |