510(k) K903725

EZ-BEAD TSH ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code JLW

K903725 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "EZ-BEAD TSH ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Immunotech Corp. has at least 10 other 510(k) clearances on record.