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FDA 510(k) Application Details - K132663
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K132663
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
ALLIANCE INTERNATIONAL CO., LTD.
NO.54 YING TAO RD.
YING DISTRICT
NEW TAIPEI CITY, 239 23942 TW
Other 510(k) Applications for this Company
Contact
JEN KE-MIN
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
08/26/2013
Decision Date
04/20/2015
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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