
Sigma Diagnostics, Inc.
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DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET is an FDA 510(k)-cleared medical device (K940569) manufactured by Sigma Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 1994. Regulation: 8.