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510(k) K222921

Minuteful-kidney test by Healthy.Io, Ltd. — Product Code JIR

K222921 is an FDA 510(k) premarket notification submitted by Healthy.Io, Ltd. for the device "Minuteful-kidney test". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Healthy.Io, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2023
Date Received
September 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

Other clearances by Healthy.Io, Ltd.

  • K210069 — Minuteful - kidney test (July 6, 2022)
  • K182384 — ACR LAB Urine Analysis Test System (July 26, 2019)
  • K173327 — DIP/U.S. Urine Analysis Test System (July 18, 2018)

Other clearances for product code JIR

  • K210069 — Minuteful - kidney test (July 6, 2022)
  • K150330 — Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (April 30, 2015)
  • K061419 — TECO MICROALBUMIN 2-1 COMBO STRIPS (January 26, 2007)
  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K001810 — URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (August 14, 2000)
  • K994035 — IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (February 1, 2000)
  • K992257 — NEW MULTIPLES REAGENT STRIPS (November 24, 1999)
  • K991315 — MICROALBUSTIX REAGENT STRIPS (OTC) (November 12, 1999)
  • K983774 — UALB (January 28, 1999)
  • K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE (October 7, 1998)

FDA data resources