
Specialized Assays, Inc.
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STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) is an FDA 510(k)-cleared medical device (K965166) manufactured by Specialized Assays, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 3, 1997. Regulation: 8.