510(k) K232715

Distinct® Digital Pregnancy Test by ACON Laboratories, Inc. — Product Code LCX

K232715 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "Distinct® Digital Pregnancy Test". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.