510(k) K221871

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx by Healstone Biotech, Inc. — Product Code NFT

K221871 is an FDA 510(k) premarket notification submitted by Healstone Biotech, Inc. for the device "Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx". The FDA issued a decision of Substantially Equivalent on August 30, 2022. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Healstone Biotech, Inc. has at least 2 other 510(k) clearances on record.