The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Thermo Scientific Mas Omni-cardio.
| Device ID | K122291 |
| 510k Number | K122291 |
| Device Name: | THERMO SCIENTIFIC MAS OMNI-CARDIO |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Microgenics Corporation 46360 FREMONT BLVD Fremont, CA 94538 -6406 |
| Contact | Karen Lee |
| Correspondent | Karen Lee Microgenics Corporation 46360 FREMONT BLVD Fremont, CA 94538 -6406 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-31 |
| Decision Date | 2012-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012004 | K122291 | 000 |
| 00884883011991 | K122291 | 000 |
| 00884883011984 | K122291 | 000 |
| 00884883011977 | K122291 | 000 |
| 00884883011960 | K122291 | 000 |
| 00884883011953 | K122291 | 000 |
| 00884883011946 | K122291 | 000 |