REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

REAGENT FOR DETERM. LACTATE/DEHYDROGENAS is an FDA 510(k)-cleared medical device (K800691) manufactured by Diagnostic Solutions, Inc.. 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 May 27, 1980. Regulation: 8.