
Hi Chem, Inc.
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ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL is an FDA 510(k)-cleared medical device (K842025) 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 21, 1984. Regulation: 8.