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FDA 510(k) Application Details - K131728
Device Classification Name
More FDA Info for this Device
510(K) Number
K131728
Device Name
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
Ronald H Lollar
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
06/12/2013
Decision Date
08/29/2013
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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