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FDA 510(k) Application Details - K100937
Device Classification Name
System, Test, Blood Glucose, Over The Counter
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510(K) Number
K100937
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
i-SENS, Inc.
465-6 WOLGYE-DONG, NOWON-GU
SEOUL 139-845 KR
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Contact
HYUN OH
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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
04/05/2010
Decision Date
12/21/2010
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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