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FDA 510(k) Application Details - K133522
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K133522
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
BIONIME COPORATION
2700 LA PAZ ROAD
SUITE 266B
MISSION VIEJO, CA 92691 US
Other 510(k) Applications for this Company
Contact
Feng-Yu Lee
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
11/15/2013
Decision Date
04/17/2014
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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