510(k) K004038

TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 by Scantibodies Laboratory, Inc. — Product Code CEW

K004038 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600". The FDA issued a decision of Substantially Equivalent on April 30, 2001. 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.