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510(k) K122435

NOVA ONE BLOOD GLUCOSE MONITOR by Nova Biomedical Corporation — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2012
Date Received
August 10, 2012
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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