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510(k) K090609

OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM by Ok Biotech Co., Ltd. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2010
Date Received
March 6, 2009
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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  • K141914 — PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM (April 15, 2015)
  • K132633 — OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM (August 14, 2014)
  • K063026 — OK METER BLOOD GLUCOSE MONITORING SYSTEM (February 9, 2007)

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