Minuteful - kidney test

FDA 510(k) K210069 · Healthy.Io, Ltd.

Substantially Equivalent

510(k) numberK210069

Submission

Device name
Minuteful - kidney test
Applicant
Healthy.Io, Ltd.
Tel Aviv, IL
Received
January 11, 2021
Decision date
July 6, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device class
Class I (low risk)
Regulation
21 CFR 862.1645
Specialty
Clinical Chemistry

Other 510(k)s with product code JIR

510(k)DeviceApplicantDecision
K222921Minuteful-kidney testJIR · Traditional Healthy.Io, Ltd.09/08/2023SE
K150330Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR · Traditional ACON Laboratories, Inc.04/30/2015SE
K061419Teco Microalbumin 2-1 Combo StripsJIR · Traditional Teco Diagnostics01/26/2007SE
K022538Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special Diagnostic Chemicals, Ltd. (Usa)08/23/2002SE
K001810Urisite Urine Collection Kit for Microalbumin/Creatinine TestingJIR · Traditional Flexsite Diagnostics, Inc.08/14/2000SE
K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15JIR · Traditional Diagnostic Chemicals , Ltd.02/01/2000SE
K992257New Multiples Reagent StripsJIR · Traditional Bayer Corp.11/24/1999SE
K991315Microalbustix Reagent Strips (OTC)JIR · Traditional Bayer Corp.11/12/1999SE
K983774UalbJIR · Traditional Abbott Laboratories01/28/1999SE
K972960Health Check Uri-Test Protein in UrineJIR · Traditional Tcpi, Inc.10/07/1998SE

More from Tcpi, Inc.

510(k)DeviceDecision
K222921Minuteful-kidney testJIR · Traditional 09/08/2023SE
K182384ACR LAB Urine Analysis Test SystemJFY · Traditional 07/26/2019SE
K173327DIP/U.S. Urine Analysis Test SystemJIL · Traditional 07/18/2018SE

Questions and answers

When was Minuteful - kidney test cleared by the FDA?

Minuteful - kidney test (K210069) received a 510(k) decision of Substantially Equivalent on July 6, 2022, 541 days after the submission was received.

What is the product code of K210069?

The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.