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FDA 510(k) Application Details - K190302
Device Classification Name
More FDA Info for this Device
510(K) Number
K190302
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 VI 8-4
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
02/12/2019
Decision Date
03/27/2019
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
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