
Tosoh Bioscience, Inc.
Free shipping on orders over $99 · 30-day returns
ST AIA PACK HBA1C is an FDA 510(k)-cleared medical device (K100304) manufactured by Tosoh Bioscience, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2010. Regulation: 8.