FDA 510(k) Application Details - K200370

Device Classification Name	More FDA Info for this Device
510(K) Number	K200370
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 A/H5 Subtyping Kit
Applicant	Centers For Disease Control And Prevention 1600 Clifton Rd; MS H24-11 Atlanta, GA 30329 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	02/14/2020
Decision Date	03/10/2020
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