K170463

Substantially Equivalent

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

Applicant: I-Sens, Inc.
Product code: JIN
Advisory panel: Clinical Chemistry
Date received: 2017-02-15
Decision date: 2018-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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