HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)

About This 510(k) Submission

K123703 is an FDA 510(k) clearance for the HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE), a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Healgen Scientific, LLC (Houston, US). The FDA issued a Cleared decision on April 10, 2013, 128 days after receiving the submission on December 3, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.