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FDA 510(k) Application Details - K120813
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K120813
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
ANDON MEDICAL CO., LTD
NO. 26 HANG YU ROAD
TIANJIN AIRPORT ECONOMIC AREA
TIANJIN 300381 CN
Other 510(k) Applications for this Company
Contact
YI LIU
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
03/19/2012
Decision Date
12/07/2012
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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