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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 the device name listed in this FDA 510(k) record. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) 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. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K242767.

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

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

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

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

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

The FDA product code for Safecare 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 Safecare Biotech (Hangzhou) 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.

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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,, LLCK252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech 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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