Cleared Traditional

MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST

K901858 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Jun 1990
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K901858 is an FDA 510(k) clearance for the MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST, a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on June 12, 1990, 49 days after receiving the submission on April 24, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K901858 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1990
Decision Date June 12, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CET — Olive Oil Emulsion (turbidimetric), Lipase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1465

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