510(k) K242077

PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup by Aicheck Biotech, Inc. — Product Code NFT

K242077 is an FDA 510(k) premarket notification submitted by Aicheck Biotech, Inc. for the device "PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup". The FDA issued a decision of Substantially Equivalent on August 14, 2024. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Aicheck Biotech, Inc. has at least 1 other 510(k) clearance on record.