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FDA 510(k), K122766, THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
FDA 510(k), K122766, THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
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510(K) Number: K122766
Device Name: THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
Manufacturer: MICROGENICS CORP.
Device Classification Name: everolimus immunoassay
Regulation Number: 862.3840
Classification Product Code: OUF
Date Received: 09/10/2012
Decision Date: 08/20/2013
Regulation Medical Specialty: Toxicology
Device Name: THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
Manufacturer: MICROGENICS CORP.
Device Classification Name: everolimus immunoassay
Regulation Number: 862.3840
Classification Product Code: OUF
Date Received: 09/10/2012
Decision Date: 08/20/2013
Regulation Medical Specialty: Toxicology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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