
Scantibodies Laboratory, Inc.
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MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT is an FDA 510(k)-cleared medical device (K060348) manufactured by Scantibodies Laboratory, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2006. Regulation: 8.