FDA 510(k) Application Details - K203429

Device Classification Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test   More FDA Info for this Device
510(K) Number	K203429
Device Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant	Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Yi-Ping Lin Other 510(k) Applications for this Contact
Regulation Number	866.3740   More FDA Info for this Regulation Number
Classification Product Code	NJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2020
Decision Date	05/09/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review