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510(k) K142089

ACCU-CHEK AVIVA EXPERT SYSTEM by Roche Diagnostics Corporation — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2014
Date Received
August 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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