510(k) K801413

AMERLEX DIGOXIN RIA KIT by Amersham Corp. — Product Code LCS

K801413 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLEX DIGOXIN RIA KIT". The FDA issued a decision of Substantially Equivalent on July 8, 1980. The device falls under product code LCS (Radioimmunoassay, Digoxin (125-I)), a Class II device regulated under 21 CFR 862.3320. Amersham Corp. has at least 10 other 510(k) clearances on record.