
Tosoh Medics, Inc.
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AIA-PACK CA 125 is an FDA 510(k)-cleared medical device (K990431) 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 June 2, 1999. Regulation: 8.