
Siemens Healthcare Diagnostics, Inc.
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ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay is an FDA 510(k)-cleared medical device (K163658) manufactured by Siemens Healthcare Diagnostics, 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 May 22, 2017. Regulation: 8.