Cleared Traditional

SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS

K970314 · Beckman Instruments, Inc. · Chemistry
Apr 1997
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K970314 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 21, 1997, 87 days after receiving the submission on January 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K970314 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1997
Decision Date April 21, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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