510(k) K926308

LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST by Princeton Biomedix — Product Code LCX

K926308 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on January 26, 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. Princeton Biomedix has at least 10 other 510(k) clearances on record.