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Provalis Diagnostics , Ltd.
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G5 I HBA1C TEST, G5 II HBA1C TEST is an FDA 510(k)-cleared medical device (K041635) manufactured by Provalis Diagnostics , Ltd.. 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 15, 2004. Regulation: 8.