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FDA 510(k) Application Details - K102481
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K102481
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU 30078 TW
Other 510(k) Applications for this Company
Contact
LISA LIU
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
08/30/2010
Decision Date
04/28/2011
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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