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FDA 510(k), K172471, VENTANA CD30 (Ber-H2) RxDx Assay
FDA 510(k), K172471, VENTANA CD30 (Ber-H2) RxDx Assay
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$149.00 USD
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510(K) Number: K172471
Device Name: VENTANA CD30 (Ber-H2) RxDx Assay
Manufacturer: Jeffrey Catania
Device Classification Name: Lambda, Antigen, Antiserum, Control
Regulation Number: DEH
Classification Product Code: 08/15/2017
Date Received: 05/08/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Molecular Genetics
Device Name: VENTANA CD30 (Ber-H2) RxDx Assay
Manufacturer: Jeffrey Catania
Device Classification Name: Lambda, Antigen, Antiserum, Control
Regulation Number: DEH
Classification Product Code: 08/15/2017
Date Received: 05/08/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Molecular Genetics
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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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