
Scantibodies Laboratory, Inc.
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TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 is an FDA 510(k)-cleared medical device (K051888) 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 October 17, 2005. Regulation: 8.