
Sorin Biomedica, Fiat, USA, Inc.
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C. PTH RADIOIMMUNOASSAY KIT-CPTHK is an FDA 510(k)-cleared medical device (K833768) manufactured by Sorin Biomedica, Fiat, USA, 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 December 28, 1983. Regulation: 8.