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

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