FDA 510(k) Application Details - K172091

Device Classification Name	More FDA Info for this Device
510(K) Number	K172091
Device Name	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit,
Applicant	Centers for Disease Control and Prevention 1600 Clifton Rd., MS E-51 Atlanta, GA 30329-4027 US Other 510(k) Applications for this Company
Contact	Yon Yu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2017
Decision Date	08/09/2017
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