510(k) K182521

FastPack IP Sex Hormone Binding Globulin Immunoassay by Qualigen, Inc. — Product Code CDZ

K182521 is an FDA 510(k) premarket notification submitted by Qualigen, Inc. for the device "FastPack IP Sex Hormone Binding Globulin Immunoassay". The FDA issued a decision of Substantially Equivalent on January 29, 2019. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Qualigen, Inc. has at least 10 other 510(k) clearances on record.