
Kallestad Laboratories, Inc.
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QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A is an FDA 510(k)-cleared medical device (K855014) manufactured by Kallestad Laboratories, 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 March 13, 1986. Regulation: 8.