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FDA 510(k) Application Details - K231481
Device Classification Name
More FDA Info for this Device
510(K) Number
K231481
Device Name
Xpert Xpress CoV-2/Flu/RSV plus
Applicant
Cepheid«
904 Caribbean Drive
Sunnyvale, CA 94089 US
Other 510(k) Applications for this Company
Contact
Suzette Chance
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QOF
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More FDA Info for this Product Code
Date Received
05/23/2023
Decision Date
08/17/2023
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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