FDA 510(k) Application Details - K190771

Device Classification Name	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen   More FDA Info for this Device
510(K) Number	K190771
Device Name	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
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	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2019
Decision Date	04/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review