
Binax, Inc.
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BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT is an FDA 510(k)-cleared medical device (K912748) manufactured by Binax, 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 October 30, 1991. Regulation: 8.