510(k) K901011

BIOSIGN HCG-ONE STEP PREGNANCY TEST by Princeton Biomedix — Product Code JHI

K901011 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "BIOSIGN HCG-ONE STEP PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on May 4, 1990. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Princeton Biomedix has at least 10 other 510(k) clearances on record.