
Scantibodies Laboratory, Inc.
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WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 is an FDA 510(k)-cleared medical device (K051810) 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 September 8, 2005. Regulation: 8.