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FDA 510(k) Application Details - K152534
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K152534
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
NO.35 AND 37, YINGCHENG STREET
HANGU 300480 CN
Other 510(k) Applications for this Company
Contact
CHAE CHUNG LYUEL
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
09/04/2015
Decision Date
03/21/2017
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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