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FDA 510(k) Application Details - K090703
Device Classification Name
Hexokinase, Glucose
More FDA Info for this Device
510(K) Number
K090703
Device Name
Hexokinase, Glucose
Applicant
POLYMEDCO, INC.
510 FURNACE DOCK RD.
CORTLANDT MANOR, NY 10567 US
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Contact
HELEN LANDICHO
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
CFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/17/2009
Decision Date
10/20/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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