AllTest Urinary Tract Infection Test— 510(k) K252607

Name: FDA 510(k) clearance K252607
Creator: U.S. Food and Drug Administration
Published: 2025-10-30

Substantially Equivalent

Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) clearance K252607 for AllTest Urinary Tract Infection Test, Substantially Equivalent on 2025-10-30. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hangzhou AllTest Biotech Co., Ltd.
Product code: Code JMT
Device class: Class 1
Regulation: 21 CFR 862.1510
Advisory panel: Clinical Chemistry
Date received: 2025-08-18
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMT

view all

K251800 — Healgen® URS Test Strips2025-12-23
K242767 — Safecare Urinary Tract Infection Test2025-01-10
K170118 — Scanostics UTI Check Application Test System2017-09-21
K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17
K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS)2000-01-03

More clearances from Hangzhou AllTest Biotech Co., Ltd.

view all

K260342 — AllTest Strep A Rapid Test2026-04-30
K251053 — Shinetell PlusTM Digital Early Pregnancy Test2025-07-15
K242576 — AllTest Viral Transport Medium2025-04-04
K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup2025-04-04
K244043 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup2025-02-27

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