510(k) K001411

WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 by Scantibodies Laboratory, Inc. — Product Code CEW

K001411 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056". The FDA issued a decision of Substantially Equivalent on August 21, 2000. 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.