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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: KXA
Date Received: 01/03/2013
Decision Date: 09/19/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: PHILIPS HERCEPTEST DIGITAL SCORE
Manufacturer: DIRK VOSSEN
Device Classification Name: Automated Digital Image Manual Interpretation Microscope
Regulation Number: OEO
Classification Product Code: KXA
Date Received: 01/03/2013
Decision Date: 09/19/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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