
Heraeus Kulzer, Inc.
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OPTIMATE HEMOGLOBIN A1C is an FDA 510(k)-cleared medical device (K896830) manufactured by Heraeus Kulzer, 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 September 10, 1990. Regulation: 8.