510(k) K060348

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT by Scantibodies Laboratory, Inc. — Product Code CEW

K060348 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT". The FDA issued a decision of Substantially Equivalent on February 27, 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.