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FDA 510(k) Application Details - K051244
Device Classification Name
More FDA Info for this Device
510(K) Number
K051244
Device Name
GENZYME OSOM INFLUENZA A & B TEST
Applicant
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE, MA 02142 US
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Contact
FRED D LASKY
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Regulation Number
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Classification Product Code
PSZ
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More FDA Info for this Product Code
Date Received
05/16/2005
Decision Date
02/21/2006
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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