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FDA 510(k) Application Details - K131363
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K131363
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
CILAG GMBH INTERNATIONAL
GUBELSTRASSE 34
ZUG 6300 CH
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Contact
Oyinkan Donaldson
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
05/13/2013
Decision Date
08/30/2013
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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