510(k) K874823

FIRST RESPONSE 5 MINUTE PREGNANCY TEST by Tambrands, Inc. — Product Code LCX

K874823 is an FDA 510(k) premarket notification submitted by Tambrands, Inc. for the device "FIRST RESPONSE 5 MINUTE PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on April 5, 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. Tambrands, Inc. has at least 10 other 510(k) clearances on record.