510(k) K862247

TARGET HCG, ENZYME IMMUNOASSAY REAGENTS by V-Tech, Inc. — Product Code JHI

K862247 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET HCG, ENZYME IMMUNOASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on July 29, 1986. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. V-Tech, Inc. has at least 10 other 510(k) clearances on record.