510(k) K950354

HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY by Ml Strategies, Inc. — Product Code LCX

K950354 is an FDA 510(k) premarket notification submitted by Ml Strategies, Inc. for the device "HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY". The FDA issued a decision of Substantially Equivalent on July 19, 1995. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Ml Strategies, Inc. has at least 3 other 510(k) clearances on record.