
Boehringer Mannheim Corp.
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ACCU-CHEK A1C HEMOGLOBIN TEST is an FDA 510(k)-cleared medical device (K974491) manufactured by Boehringer Mannheim Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 1998. Regulation: 8.