The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Qms Everolimus Reagents, Calibrators And Controls.
| Device ID | K100144 |
| 510k Number | K100144 |
| Device Name: | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS |
| Classification | Everolimus Immunoassay |
| 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 | OUF |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2011-02-11 |
| Summary: | summary |