510(k) K903391

ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM by Nichols Institute — Product Code JLW

K903391 is an FDA 510(k) premarket notification submitted by Nichols Institute for the device "ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM". The FDA issued a decision of Substantially Equivalent on October 12, 1990. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Nichols Institute has at least 10 other 510(k) clearances on record.