
Tosoh Medics, Inc.
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AIA-PACK FOLATE ASSAY is an FDA 510(k)-cleared medical device (K992365) manufactured by Tosoh Medics, 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 August 9, 1999. Regulation: 8.