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SAP – KidneyIntelX.Dkd (DEN200052, Renalytix AI, Inc.)
SAP – KidneyIntelX.Dkd (DEN200052, Renalytix AI, Inc.)
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$69.00 USD
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510(K) Number:
Device Name:
Manufacturer:
Device Classification Name:
Regulation Number:
Classification Product Code:
Date Received: 01/00/1900
Decision Date: 01/00/1900
Regulation Medical Specialty:
Request Contents: Statistical Analysis Plan (SAP) for DEN200052, corresponding to KidneyIntelX.Dkd (Renalytix AI, Inc.).
Device Name:
Manufacturer:
Device Classification Name:
Regulation Number:
Classification Product Code:
Date Received: 01/00/1900
Decision Date: 01/00/1900
Regulation Medical Specialty:
Request Contents: Statistical Analysis Plan (SAP) for DEN200052, corresponding to KidneyIntelX.Dkd (Renalytix AI, Inc.).
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- 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.
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