510(k) K904666

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 by Amersham Corp. — Product Code JLW

K904666 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008". The FDA issued a decision of Substantially Equivalent on November 2, 1990. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Amersham Corp. has at least 10 other 510(k) clearances on record.