
Sigma Diagnostics, Inc.
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SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 is an FDA 510(k)-cleared medical device (K992712) manufactured by Sigma Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 1999. Regulation: 8.