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FDA 510(k), K223046, Xpert® FII & FV
FDA 510(k), K223046, Xpert® FII & FV
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510(K) Number: K223046
Device Name: Xpert® FII & FV
Manufacturer: Suzette Chance
Device Classification Name: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Regulation Number: NPR
Classification Product Code: 09/29/2022
Date Received: 02/15/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: Xpert® FII & FV
Manufacturer: Suzette Chance
Device Classification Name: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Regulation Number: NPR
Classification Product Code: 09/29/2022
Date Received: 02/15/2023
Decision Date: Substantially Equivalent (SESE)
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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