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FDA 510(k) Application Details - K143387
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K143387
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
Bionime Coporation
No. 100, Sec. 2, Daqing St., South Dist.
Taichung 40242 TW
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Contact
Tino Lee
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
11/26/2014
Decision Date
06/03/2015
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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