510(k) K231045

Healgen URS Test Strips by Healgen Scientific,, LLC — Product Code LJX

K231045 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 June 16, 2023. The device falls under product code LJX (Test, Urine Leukocyte), a Class I device regulated under 21 CFR 864.7675. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.