510(k) K844408

AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED by Amersham Corp. — Product Code CGI

K844408 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. Amersham Corp. has at least 10 other 510(k) clearances on record.