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FDA 510(k) Application Details - K132406
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K132406
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
INFOPIA CO., LTD
2651 E CHAPMAN AVE STE 110
FULLERTON, CA 92833 US
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Contact
Priscilla Chung
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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
08/02/2013
Decision Date
04/18/2014
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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