510(k) K102175

RAPIDVUE HCG TEST by Quidel Corporation — Product Code JHI

K102175 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "RAPIDVUE HCG TEST". The FDA issued a decision of Substantially Equivalent on August 25, 2010. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Quidel Corporation has at least 10 other 510(k) clearances on record.