510(k) K060420

MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 by Scantibodies Laboratory, Inc. — Product Code CEW

K060420 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002". The FDA issued a decision of Substantially Equivalent on March 1, 2006. 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.