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510(k) K181131

Accu-Chek Guide Me Blood Glucose Monitoring System by Roche Diabetes Care — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2018
Date Received
April 30, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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