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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 K250218
Device Name Xpert® FII & FV
Applicant
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact Sruti Krishna
Regulation Number864.7280
Classification Product Code
NPR  
Subsequent Product Code
NPQ  
Date Received01/24/2025
Decision Date 02/21/2025
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
Predetermined Change
Control Plan Authorized		 No
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