510(k) K102760

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 by Atlas Medical — Product Code LCX

K102760 is an FDA 510(k) premarket notification submitted by Atlas Medical for the device "ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001". The FDA issued a decision of Substantially Equivalent on August 3, 2011. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Atlas Medical has at least 1 other 510(k) clearance on record.