510(k) K973352

BRAND NAME *1-STEP PREGNANCY by Armkel, LLC — Product Code LCX

K973352 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "BRAND NAME *1-STEP PREGNANCY". The FDA issued a decision of Substantially Equivalent on October 27, 1997. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Armkel, LLC has at least 10 other 510(k) clearances on record.