ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT is an FDA 510(k)-cleared medical device (K941001) 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 29, 1994. Regulation: 8.