510(k) K971834

ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA by Monobind — Product Code JNL

K971834 is an FDA 510(k) premarket notification submitted by Monobind for the device "ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA". The FDA issued a decision of Substantially Equivalent on July 3, 1997. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Monobind has at least 10 other 510(k) clearances on record.