Minuteful - kidney test— 510(k) K210069

Substantially Equivalent

Healthy.Io, Ltd.

FDA 510(k) clearance K210069 for Minuteful - kidney test, Substantially Equivalent on 2022-07-06. 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: 2021-01-11
Decision date: 2022-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIR

K222921 — Minuteful-kidney test2023-09-08
K150330 — Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)2015-04-30
K061419 — TECO MICROALBUMIN 2-1 COMBO STRIPS2007-01-26
K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-252002-08-23
K001810 — URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING2000-08-14

More clearances from Healthy.Io, Ltd.

K182384 — ACR LAB Urine Analysis Test System2019-07-26
K173327 — DIP/U.S. Urine Analysis Test System2018-07-18

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