510(k) K030860

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 by Monobind — Product Code KLI

K030860 is an FDA 510(k) premarket notification submitted by Monobind for the device "ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300". The FDA issued a decision of Substantially Equivalent on August 22, 2003. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Monobind has at least 10 other 510(k) clearances on record.