510(k) K882588

BLUE DOT(TM) TEST FOR PREGNANCY by V-Tech, Inc. — Product Code LCX

K882588 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "BLUE DOT(TM) TEST FOR PREGNANCY". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. V-Tech, Inc. has at least 10 other 510(k) clearances on record.