510(k) K043231

PROOF POSITIVE ELECTRONIC PREGNANCY TEST by Mizuho USA, Inc. — Product Code LCX

K043231 is an FDA 510(k) premarket notification submitted by Mizuho USA, Inc. for the device "PROOF POSITIVE ELECTRONIC PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on Apr 25, 2005. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Mizuho USA, Inc. has 6 other 510(k) clearances on record.