Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Healgen® URS Test Strips

K-Number: K251800 · 2025-12-23

ApplicantHealgen Scientific,, LLC
Decision Date2025-12-23
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Healgen® URS Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251800. 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 Healgen® URS Test Strips?

Healgen® URS Test Strips is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K251800.

When did Healgen® URS Test Strips receive FDA 510(k) clearance?

Healgen® URS Test Strips received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251800.

Who is the listed applicant for Healgen® URS Test Strips?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healgen® URS Test Strips?

The FDA product code for Healgen® URS Test Strips is JMT.

Other records listing Healgen Scientific,, LLC 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.

K260095Heal-Check Rapid COVID-19 Antigen Self-TestK253705Healgen® Accurate Oral Fluid Drug TestK252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestK253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

View all 15 devices →

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.

K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.K242767Safecare 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.

↑