SPIN CHEM CK-NAC REAGENT

SPIN CHEM CK-NAC REAGENT is an FDA 510(k)-cleared medical device (K790917) manufactured by Smithkline Diagnostics, 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 June 21, 1979. Regulation: 8.