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FDA 510(k), K212361, Novo
FDA 510(k), K212361, Novo
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510(K) Number: K212361
Device Name: Novo
Manufacturer: Kathy Wack
Device Classification Name: Digital Pathology Image Viewing And Management Software
Regulation Number: QKQ
Classification Product Code: 07/30/2021
Date Received: 08/11/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: Novo
Manufacturer: Kathy Wack
Device Classification Name: Digital Pathology Image Viewing And Management Software
Regulation Number: QKQ
Classification Product Code: 07/30/2021
Date Received: 08/11/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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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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