PROTEIN-BOUND GLUCOSE ASSAYN KIT

PROTEIN-BOUND GLUCOSE ASSAYN KIT is an FDA 510(k)-cleared medical device (K930823) manufactured by Diagnostic Specialties. 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 18, 1993. Regulation: 8.