
E.I. Dupont DE Nemours & Co., Inc.
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MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST is an FDA 510(k)-cleared medical device (K901858) manufactured by E.I. Dupont DE Nemours & Co., Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 11, 1990. Regulation: 8.