KetoSens BT Blood B-Ketone Monitoring System— 510(k) K201551

Substantially Equivalent

I-Sens, Inc.

FDA 510(k) clearance K201551 for KetoSens BT Blood B-Ketone Monitoring System, Substantially Equivalent on 2020-09-09. Applicant: I-Sens, Inc..

Clearance details

Applicant: I-Sens, Inc.
Product code: Code JIN
Advisory panel: Clinical Chemistry
Date received: 2020-06-09
Decision date: 2020-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.