510(k) K860130

TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT by Cambridge Medical Technology — Product Code CDZ

K860130 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on February 19, 1986. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.