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FDA 510(k)

AllTest Urinary Tract Infection Test

K-Number: K252607 · 2025-10-30

ApplicantHangzhou AllTest Biotech Co., Ltd.
Decision Date2025-10-30
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AllTest Urinary Tract Infection Test is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under approval number K252607. The device is classified under product code JMT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllTest Urinary Tract Infection Test?

AllTest Urinary Tract Infection Test is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K252607.

When was AllTest Urinary Tract Infection Test approved by the FDA?

AllTest Urinary Tract Infection Test received FDA 510(k) clearance on 2025-10-30, under approval number K252607.

What company makes AllTest Urinary Tract Infection Test?

AllTest Urinary Tract Infection Test is manufactured by Hangzhou AllTest Biotech Co., Ltd..

What is the FDA product code for AllTest Urinary Tract Infection Test?

The FDA product code for AllTest Urinary Tract Infection Test is JMT.

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Related PubMed Literature

PMID: 42096274 Nanoparticle-based approaches to tackling urinary tract biofilms. Nanomedicine (London, England) (2026) PMID: 41229180 What Is Required for AI to Improve the Assessment and Treatment of Patients With Lower Urinary Tract Dysfunction? ICI-RS 2025. Neurourology and urodynamics (2025)

Other Devices by Hangzhou AllTest Biotech Co., Ltd.

K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) K203272Alltest Pregnancy Rapid Combo Test Cassette K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx K233417AllTest Fentanyl Urine Test Cassette K231698AllTest Fentanyl Rapid Test (Urine) K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

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Related Devices (Code: JMT)

K170118Scanostics UTI Check Application Test SystemTeco Diagnostics K251800Healgen® URS Test StripsHealgen Scientific,, LLC K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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