
Flexsite Diagnostics, Inc.
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EZCHEK/HBA BLOOD COLLECTION KIT is an FDA 510(k)-cleared medical device (K971919) manufactured by Flexsite Diagnostics, 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 4, 1997. Regulation: 8.