CREATINE KINASE LIQUID REAGENT, MODEL C519-440

CREATINE KINASE LIQUID REAGENT, MODEL C519-440 is an FDA 510(k)-cleared medical device (K072548) manufactured by Teco Diagnostics. 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 April 17, 2008. Regulation: 8.