
Sigma Diagnostics, Inc.
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TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS is an FDA 510(k)-cleared medical device (K952557) manufactured by Sigma 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 January 23, 1996. Regulation: 8.