510(k) K842593

SUCROSEP THYROID STIMULATING HORMONE by Boots-Celltech Diagnostics, Inc. — Product Code JLW

K842593 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "SUCROSEP THYROID STIMULATING HORMONE". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.