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.. Device class: 1.

Clearance details

Applicant: Healthy.Io, Ltd.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 2022-09-26
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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K001810 — URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING2000-08-14

More clearances from Healthy.Io, Ltd.

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