
Kallestad Diag, A Div. of Erbamont, Inc.
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QM300 APOLIPOPROTEIN A-I ANTIBODY PACK is an FDA 510(k)-cleared medical device (K883713) manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 18, 1988. Regulation: 8.