510(k) K023126

AMEDITECH IMMUTEST HCG PREGANCY TEST by Ameditech, Inc. — Product Code LCX

K023126 is an FDA 510(k) premarket notification submitted by Ameditech, Inc. for the device "AMEDITECH IMMUTEST HCG PREGANCY TEST". The FDA issued a decision of Substantially Equivalent on November 18, 2002. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Ameditech, Inc. has at least 10 other 510(k) clearances on record.