510(k) K924257

TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY by Serono-Baker Diagnostics, Inc. — Product Code CDZ

K924257 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Nov 30, 1992. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.