Cleared Traditional

OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER

K920942 · Olympus Corp. · Chemistry
Jun 1992
Decision
104d
Days
Class 1
Risk

About This 510(k) Submission

K920942 is an FDA 510(k) clearance for the OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER, a Analyzer, Chemistry, Centrifugal, For Clinical Use (Class I — General Controls, product code JJG), submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on June 10, 1992, 104 days after receiving the submission on February 27, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2140.

Submission Details

510(k) Number K920942 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1992
Decision Date June 10, 1992
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJG — Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2140

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