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FDA 510(k) Application Details - K181131
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K181131
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
Roche Diabetes Care
9115 Hague Road
Indianapolis, IN 46250 US
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Contact
Ginger Emrich
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
04/30/2018
Decision Date
12/13/2018
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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