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510(k) K152599

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2016
Date Received
September 11, 2015
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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