
Kallestad Diag, A Div. of Erbamont, Inc.
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QM2/QM300 CONTROL B PACK is an FDA 510(k)-cleared medical device (K875283) manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 1988. Regulation: 8.