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 a medical device manufactured by Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2025-12-23 under approval 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. It is manufactured by Healgen Scientific,, LLC. The 510(k) number is K251800.
When was Healgen® URS Test Strips approved by the FDA?
Healgen® URS Test Strips received FDA 510(k) clearance on 2025-12-23, under approval number K251800.
What company makes Healgen® URS Test Strips?
Healgen® URS Test Strips is manufactured by Healgen Scientific,, LLC.
What is the FDA product code for Healgen® URS Test Strips?
The FDA product code for Healgen® URS Test Strips is JMT.
Other Devices by Healgen Scientific,, LLC
K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
K212623Healgen Strep A Rapid Test Strip (Throat Swab)
K231045Healgen URS Test Strips
K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
Related Devices (Code: JMT)
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.