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510(k) K160038

UniStrip1 Generic Blood Glucose Test Strips by Ok Biotech Co., Ltd. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2016
Date Received
January 7, 2016
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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  • K132633 — OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM (August 14, 2014)
  • K090609 — OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM (February 4, 2010)
  • K063026 — OK METER BLOOD GLUCOSE MONITORING SYSTEM (February 9, 2007)

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