510(k) K240295

InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) by Instanosis, Inc. — Product Code NGL

K240295 is an FDA 510(k) premarket notification submitted by Instanosis, Inc. for the device "InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)". The FDA issued a decision of Substantially Equivalent on March 28, 2024. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650.