Minuteful-kidney test— 510(k) K222921

Substantially Equivalent

Healthy.Io, Ltd.

FDA 510(k) clearance K222921 for Minuteful-kidney test, Substantially Equivalent on 2023-09-08. Applicant: Healthy.Io, Ltd..

Clearance details

Applicant: Healthy.Io, Ltd.
Product code: Code JIR
Advisory panel: Clinical Chemistry
Date received: 2022-09-26
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

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