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FDA 510(k) Application Details - K051514
Device Classification Name
System, Test, Blood Glucose, Over The Counter
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510(K) Number
K051514
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
HYPOGUARD USA, INC.
5182 WEST 76TH ST.
MINNEAPOLIS, MN 55439 US
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BRUCE A MACFARLANE
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Regulation Number
862.1345
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Classification Product Code
NBW
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More FDA Info for this Product Code
Date Received
06/08/2005
Decision Date
10/04/2005
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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