
Sigma Diagnostics, Inc.
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INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) is an FDA 510(k)-cleared medical device (K001569) 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 June 25, 2000. Regulation: 8.