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FDA 510(k) Application Details - K983399
Device Classification Name
Giardia Spp.
More FDA Info for this Device
510(K) Number
K983399
Device Name
Giardia Spp.
Applicant
GENZYME DIAGNOSTICS
ONE KENDALL SQUARE
CAMBRIDGE, MA 02139-1562 US
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Contact
BARBARA PIZZA
Other 510(k) Applications for this Contact
Regulation Number
866.3220
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Classification Product Code
MHI
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More FDA Info for this Product Code
Date Received
09/28/1998
Decision Date
01/11/1999
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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