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FDA 510(k) Application Details - K011843
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K011843
Device Name
Catalytic Methods, Amylase
Applicant
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE, MA 02142-1562 US
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Contact
BARBARA PIZZA
Other 510(k) Applications for this Contact
Regulation Number
862.1070
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Classification Product Code
JFJ
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More FDA Info for this Product Code
Date Received
06/12/2001
Decision Date
08/10/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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