FDA 510(k), K100144, THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
FDA 510(k), K100144, THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
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510(K) Number: K100144
Device Name: THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
Manufacturer: MICROGENICS CORP.
Device Classification Name: everolimus immunoassay
Regulation Number: 862.3840
Classification Product Code: OUF
Date Received: 01/19/2010
Decision Date: 02/11/2011
Regulation Medical Specialty: Toxicology
Device Name: THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
Manufacturer: MICROGENICS CORP.
Device Classification Name: everolimus immunoassay
Regulation Number: 862.3840
Classification Product Code: OUF
Date Received: 01/19/2010
Decision Date: 02/11/2011
Regulation Medical Specialty: Toxicology
- 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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