CALIBRATION PACK, MODELS A9100-101S AND A9100-103S

CALIBRATION PACK, MODELS A9100-101S AND A9100-103S is an FDA 510(k)-cleared medical device (K023792) manufactured by Thermo Orion. 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 January 30, 2003. Regulation: 8.