KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System— 510(k) K170463

Substantially Equivalent

I-Sens, Inc.

FDA 510(k) clearance K170463 for KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System, Substantially Equivalent on 2018-04-13. Applicant: I-Sens, Inc..

Clearance details

Applicant: I-Sens, Inc.
Product code: 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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