510(k) K925189

PREGNAGEN 1-STEP PREGNANCY TEST by Biogenex Laboratories — Product Code LCX

K925189 is an FDA 510(k) premarket notification submitted by Biogenex Laboratories for the device "PREGNAGEN 1-STEP PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on January 6, 1993. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Biogenex Laboratories has at least 10 other 510(k) clearances on record.