510(k) K892654

BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST by Princeton Biomedix — Product Code DHA

K892654 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on June 19, 1989. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Princeton Biomedix has at least 10 other 510(k) clearances on record.