510(k) K240949

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) by Healgen Scientific,, LLC — Product Code NGL

K240949 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)". The FDA issued a decision of Substantially Equivalent on May 13, 2024. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.