
Iso-Tex Diagnostics
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RIA SYSTEM, PARATHYROID HORMONE is an FDA 510(k)-cleared medical device (K782081) manufactured by Iso-Tex Diagnostics. 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 March 20, 1979. Regulation: 8.