The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Thermo Scientific Mas R Doa Total.
| Device ID | K103656 |
| 510k Number | K103656 |
| Device Name: | THERMO SCIENTIFIC MAS R DOA TOTAL |
| Classification | Drug Mixture Control Materials |
| 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 | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-15 |
| Decision Date | 2011-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004733 | K103656 | 000 |
| 00884883004726 | K103656 | 000 |
| 00884883004719 | K103656 | 000 |
| 00884883004702 | K103656 | 000 |
| 00884883004696 | K103656 | 000 |
| 00884883004689 | K103656 | 000 |
| 00884883004672 | K103656 | 000 |