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510(k) K141914

PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM by Ok Biotech Co., Ltd. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2015
Date Received
July 15, 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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  • K090609 — OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM (February 4, 2010)
  • K063026 — OK METER BLOOD GLUCOSE MONITORING SYSTEM (February 9, 2007)

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