FDA 510(k), K130021, PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k), K130021, PHILIPS HERCEPTEST DIGITAL SCORE

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510(K) Number: K130021
Device Name: PHILIPS HERCEPTEST DIGITAL SCORE
Manufacturer: DIRK VOSSEN
Device Classification Name: Automated Digital Image Manual Interpretation Microscope
Regulation Number: OEO
Classification Product Code: 01/03/2013
Date Received: 09/19/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology

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