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FDA 510(k) Application Details - K192220
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K192220
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu
Seoul 06646 KR
Other 510(k) Applications for this Company
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/15/2019
Decision Date
12/13/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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