510(k) K901484

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC by London Diagnostics, Inc. — Product Code JHI

K901484 is an FDA 510(k) premarket notification submitted by London Diagnostics, Inc. for the device "LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC". The FDA issued a decision of Substantially Equivalent on May 1, 1990. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. London Diagnostics, Inc. has at least 10 other 510(k) clearances on record.