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FDA 510(k) Application Details - K160430
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K160430
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
Ascensia Diabetes Care US Inc.
430 South Beiger Street
Mishawaka, IN 46544 US
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Contact
Jennifer L. Gregory
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
02/16/2016
Decision Date
06/24/2016
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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