FDA 510(k) Application Details - K223046

Device Classification Name	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	K223046
Device Name	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Applicant	Cepheid« 904 Caribbean Drive Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Suzette Chance Other 510(k) Applications for this Contact
Regulation Number	864.7280   More FDA Info for this Regulation Number
Classification Product Code	NPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2022
Decision Date	02/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review