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FDA 510(k), K131140, OMNYX IDP FOR HER2 MANUAL APPLICATION
FDA 510(k), K131140, OMNYX IDP FOR HER2 MANUAL APPLICATION
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510(K) Number: K131140
Device Name: OMNYX IDP FOR HER2 MANUAL APPLICATION
Manufacturer: OMNYX, LLC
Device Classification Name: automated digital image manual interpretation microscope
Regulation Number: 864.1860
Classification Product Code: OEO
Date Received: 04/22/2013
Decision Date: 04/01/2014
Regulation Medical Specialty: Hematology
Device Name: OMNYX IDP FOR HER2 MANUAL APPLICATION
Manufacturer: OMNYX, LLC
Device Classification Name: automated digital image manual interpretation microscope
Regulation Number: 864.1860
Classification Product Code: OEO
Date Received: 04/22/2013
Decision Date: 04/01/2014
Regulation Medical Specialty: Hematology
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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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