510(k) K831345

RIANEN PROLACTIN 125I KIT by New England Nuclear — Product Code CFT

K831345 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "RIANEN PROLACTIN 125I KIT". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. New England Nuclear has at least 10 other 510(k) clearances on record.