Cleared Traditional

AllTest Urinary Tract Infection Test

K252607 · Hangzhou AllTest Biotech Co., Ltd. · Chemistry
Oct 2025
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K252607 is an FDA 510(k) clearance for the AllTest Urinary Tract Infection Test, a Diazo (colorimetric), Nitrite (urinary, Non-quant) (Class I — General Controls, product code JMT), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 30, 2025, 73 days after receiving the submission on August 18, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1510.

Submission Details

510(k) Number K252607 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2025
Decision Date October 30, 2025
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMT — Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1510

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