AllTest Urinary Tract Infection Test— 510(k) K252607

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..

Clearance details

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

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