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FDA 510(k) Application Details - K140210
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K140210
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
BIONIME CORPORATION
29222 RANCHO VIEJO ROAD
SUITE 218
SAN JUN CAPISTRANO, CA 92675 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
01/28/2014
Decision Date
08/22/2014
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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