510(k) K854972

V-TREND DIG ENZYME IMMUNOASSAY TEST KIT by V-Tech, Inc. — Product Code KXT

K854972 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "V-TREND DIG ENZYME IMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on January 22, 1986. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. V-Tech, Inc. has at least 10 other 510(k) clearances on record.