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510(k) K142785

PRODIGY iConnect Blood Glucose Monitoring System by Ok Biotech Co., Ltd. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
September 26, 2014
Clearance Type
Traditional
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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  • K063026 — OK METER BLOOD GLUCOSE MONITORING SYSTEM (February 9, 2007)

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