510(k) K894091

AMERLEX-MAB FT4 KIT by Amersham Corp. — Product Code CEC

K894091 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLEX-MAB FT4 KIT". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Amersham Corp. has at least 10 other 510(k) clearances on record.