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FDA 510(k) Application Details - K103610
Device Classification Name
More FDA Info for this Device
510(K) Number
K103610
Device Name
CLEARVIEW EXACT II INFLUENZA A & B TEST
Applicant
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
10 Southgate Road
Scarborough, ME 04074 US
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Contact
Anne Jepson
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Regulation Number
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Classification Product Code
PSZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2010
Decision Date
01/06/2011
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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