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FDA 510(k) Application Details - K113777
Device Classification Name
More FDA Info for this Device
510(K) Number
K113777
Device Name
QUIDEL MOLECULAR INFLUENZA A+B
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO, CA 92121 US
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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
12/21/2011
Decision Date
03/15/2012
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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