510(k) K841573

INSULIN RADIOIMMUNOASSAY KIT by Sorin Biomedica, Fiat, USA, Inc. — Product Code CFP

K841573 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "INSULIN RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on May 16, 1984. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.