
Sigma Diagnostics, Inc.
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ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 is an FDA 510(k)-cleared medical device (K000528) manufactured by Sigma Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 6, 2000. Regulation: 8.