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FDA 510(k)

Safecare Urinary Tract Infection Test

K-Number: K242767 · 2025-01-10

ApplicantSafecare Biotech (Hangzhou) Co., Ltd.
Decision Date2025-01-10
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Safecare Urinary Tract Infection Test is a medical device manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2025-01-10 under approval number K242767. 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 Safecare Urinary Tract Infection Test?

Safecare Urinary Tract Infection Test is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K242767.

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

Safecare Urinary Tract Infection Test received FDA 510(k) clearance on 2025-01-10, under approval number K242767.

What company makes Safecare Urinary Tract Infection Test?

Safecare Urinary Tract Infection Test is manufactured by Safecare Biotech (Hangzhou) Co., Ltd..

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

The FDA product code for Safecare 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 Safecare Biotech (Hangzhou) Co., Ltd.

K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana K182654SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card K191924SAFECARE® THC Urine Strip Test K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream K201120SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

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Related Devices (Code: JMT)

K170118Scanostics UTI Check Application Test SystemTeco Diagnostics K251800Healgen® URS Test StripsHealgen Scientific,, LLC K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech 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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