STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ

STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ is an FDA 510(k)-cleared medical device (K843452) manufactured by Fisher Scientific Co., LLC. 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 26, 1984. Regulation: 8.