510(k) K833768

C. PTH RADIOIMMUNOASSAY KIT-CPTHK by Sorin Biomedica, Fiat, USA, Inc. — Product Code CEW

K833768 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "C. PTH RADIOIMMUNOASSAY KIT-CPTHK". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.