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FDA 510(k) Application Details - K090389
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K090389
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
BESTGEN BIOTECH CORP.
NO. 58 FU CHIUN STREET
HSIN CHU CITY 30067 TW
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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
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More FDA Info for this Product Code
Date Received
02/17/2009
Decision Date
07/14/2009
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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