510(k) K251800

Healgen® URS Test Strips by Healgen Scientific,, LLC — Product Code JMT

K251800 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen® URS Test Strips". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), a Class I device regulated under 21 CFR 862.1510. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.