
Alpha-Tec Systems, Inc.
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ATS TB RAPID STAIN SET PRODUCT #034-45 is an FDA 510(k)-cleared medical device (K890148) manufactured by Alpha-Tec Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 23, 1989. Regulation: 8.