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FDA 510(k) Application Details - K133346
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K133346
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
i-SENS, Inc.
27-36 GWANGUN-RO, NOWON-GU
SEOUL, KOREA 139-845 KR
Other 510(k) Applications for this Company
Contact
HYE YOUNG KANG
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2013
Decision Date
12/19/2013
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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