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FDA 510(k) Application Details - K151164
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K151164
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
i-Sens, Inc.
43, BANPO-DAERO 28-GIL, SEOCHO-GU
SEOUL 137-873 KR
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Contact
JOON HO JUNG
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
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More FDA Info for this Product Code
Date Received
05/01/2015
Decision Date
08/07/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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