510(k) K031534

CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 by Scantibodies Laboratory, Inc. — Product Code CEW

K031534 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001". The FDA issued a decision of Substantially Equivalent on July 30, 2003. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.