510(k) K063437

ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 by Monobind, Inc. — Product Code JLW

K063437 is an FDA 510(k) premarket notification submitted by Monobind, Inc. for the device "ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300". The FDA issued a decision of Substantially Equivalent on April 4, 2008. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Monobind, Inc. has at least 10 other 510(k) clearances on record.