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FDA 510(k) Application Details - K113007
Device Classification Name
Calculator/Data Processing Module, For Clinical Use
More FDA Info for this Device
510(K) Number
K113007
Device Name
Calculator/Data Processing Module, For Clinical Use
Applicant
BIONIME CORPORATION
27001 LA PAZ RD.
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
862.2100
More FDA Info for this Regulation Number
Classification Product Code
JQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2011
Decision Date
02/27/2012
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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