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Tosoh Medics, Inc.
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ST AIA-PACK AFP ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K023894) manufactured by Tosoh Medics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2002. Regulation: 8.