HICHEM ION 2/4 URINE RANGE CALIBRATOR

HICHEM ION 2/4 URINE RANGE CALIBRATOR is an FDA 510(k)-cleared medical device (K842450) 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 August 15, 1984. Regulation: 8.