510(k) K122766
K122766 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY". The FDA issued a decision of Substantially Equivalent on August 20, 2013. The device falls under product code OUF (Everolimus Immunoassay), a Class II device regulated under 21 CFR 862.3840. Microgenics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2013
- Date Received
- September 10, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Everolimus Immunoassay
- Device Class
- Class II
- Regulation Number
- 862.3840
- Review Panel
- TX
- Submission Type
To quantify everolimus in whole blood.