TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL is an FDA 510(k)-cleared medical device (K921252) manufactured by Hybritech, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 16, 1992. Regulation: 8.