1
/
of
0
FDA 510(k), K172471, VENTANA CD30 (Ber-H2) RxDx Assay
FDA 510(k), K172471, VENTANA CD30 (Ber-H2) RxDx Assay
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
Unit price
/
per
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: KXA
Date Received: 08/15/2017
Decision Date: 05/08/2018
Decision: 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: KXA
Date Received: 08/15/2017
Decision Date: 05/08/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Molecular Genetics
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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.
View full details