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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, factor ii g20210a mutations, genomic dna pcr
510(k) Number K223046
Device Name Xpert® FII & FV
Applicant
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid®
904 Caribbean Drive
Sunnyvale,  CA  94089
Correspondent Contact Bobbi L Ferrell
Regulation Number864.7280
Classification Product Code
NPR  
Subsequent Product Codes
NPQ   OOI  
Date Received09/29/2022
Decision Date 02/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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