Home / 510(k) Clearances / K170143

510(k) K170143

GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, by Bionime Corporation — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2017
Date Received
January 17, 2017
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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