ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS

ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS is an FDA 510(k)-cleared medical device (K942549) manufactured by Alko Diagnostic Corp.. 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 July 27, 1994. Regulation: 8.