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FDA 510(k) Application Details - K133637
Device Classification Name
More FDA Info for this Device
510(K) Number
K133637
Device Name
ALERE INFLUENZA A & B TEST
Applicant
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
10 Southgate Rd
Scarborough, ME 04074 US
Other 510(k) Applications for this Company
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
11/07/2013
Decision Date
12/18/2013
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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