MEDI-TEST COMBI 11

MEDI-TEST COMBI 11 is an FDA 510(k)-cleared medical device (K991927) manufactured by Macherey-Nagel-Duren. 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 September 16, 1999. Regulation: 8.