510(k) K840588

AMERLEX HUMAN PLACENTAL LACTOGEN by Amersham Corp. — Product Code JMF

K840588 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLEX HUMAN PLACENTAL LACTOGEN". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code JMF (Radioimmunoassay, Human Placental Lactogen), a Class II device regulated under 21 CFR 862.1585. Amersham Corp. has at least 10 other 510(k) clearances on record.