
Hichem Diagnostics
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HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 is an FDA 510(k)-cleared medical device (K925552) manufactured by Hichem Diagnostics. 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 February 11, 1993. Regulation: 8.