Cleared Traditional

VIGIL LIPID CONTROL

K974452 · Beckman Instruments, Inc. · Chemistry
Dec 1997
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K974452 is an FDA 510(k) clearance for the VIGIL LIPID CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on December 17, 1997, 22 days after receiving the submission on November 25, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K974452 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1997
Decision Date December 17, 1997
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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