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FDA 510(k) Application Details - K092223
Device Classification Name
More FDA Info for this Device
510(K) Number
K092223
Device Name
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
Applicant
BINAX, INC.
10 SOUTHGATE RD.
SCARBOROUGH, ME 04074 US
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Contact
Angela Drysdale
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PSZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2009
Decision Date
08/12/2009
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
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