
Hana Biologics, Inc.
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AMNIO STAT-FLM AGGLUTINATION TEST is an FDA 510(k)-cleared medical device (K834616) manufactured by Hana Biologics, 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 24, 1984. Regulation: 8.