LDP REAGENT CARTRIDGE (NO. 88216)

LDP REAGENT CARTRIDGE (NO. 88216) is an FDA 510(k)-cleared medical device (K862027) manufactured by Hi Chem, 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 12, 1986. Regulation: 8.