510(k) K120009

TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) by Abbott Laboratories — Product Code CDZ

K120009 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)". The FDA issued a decision of Substantially Equivalent on September 11, 2012. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Abbott Laboratories has at least 10 other 510(k) clearances on record.