
Sigma Diagnostics, Inc.
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GLUCOSE (HK) REAGENT (PROCEDURE NO.16) is an FDA 510(k)-cleared medical device (K945908) 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 May 7, 1995. Regulation: 8.