
Bio-Rad Laboratories, Inc.
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HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI is an FDA 510(k)-cleared medical device (K090737) manufactured by Bio-Rad Laboratories, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2009. Regulation: 8.