
Biosafe Laboratories, Inc.
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SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC is an FDA 510(k)-cleared medical device (K991850) manufactured by Biosafe Laboratories, 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 November 25, 1999. Regulation: 8.