510(k) K962183

BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES by Armkel, LLC — Product Code LCX

K962183 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES". The FDA issued a decision of Substantially Equivalent on July 10, 1996. 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.