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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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) 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. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K252607.

When did AllTest Urinary Tract Infection Test receive FDA 510(k) clearance?

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

Who is the listed applicant for AllTest Urinary Tract Infection Test?

The FDA 510(k) record lists Hangzhou AllTest Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06976125Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory SettingRECRUITINGNCT07759986Anti-fouling Silicone Urinary Catheter for Adults Needing Long-term Catheterisation: a Pilot and Feasibility StudyCOMPLETEDNCT06769087Comparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer SurgeryENROLLING_BY_INVITATIONNCT06815120A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ StentRECRUITINGNCT06984484Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux DiseaseRECRUITINGNCT07161024AR Projections for Eye-gaze Evaluation in PhantomsCOMPLETED

Other records listing Hangzhou AllTest Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260342AllTest Strep A Rapid TestK251053Shinetell PlusTM Digital Early Pregnancy TestK250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupK242576AllTest Viral Transport MediumK244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupK242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

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Related Devices (Code: JMT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251800Healgen® URS Test StripsHealgen Scientific,, LLCK242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.K170118Scanostics UTI Check Application Test SystemTeco Diagnostics

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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