510(k) K854971

V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT by V-Tech, Inc. — Product Code KLI

K854971 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on February 6, 1986. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. V-Tech, Inc. has at least 10 other 510(k) clearances on record.