Cleared Traditional

OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (K920942) - FDA 510(k) Clearance

Class I Chemistry device.

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

K920942 is an FDA 510(k) clearance for the OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on June 10, 1992 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Corp. devices

Submission Details

510(k) Number K920942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 11
Devices cleared under the same product code (JJG) and FDA review panel - the closest regulatory comparables to K920942.
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K893641 · Roche Diagnostic Systems, Inc. · Jul 1989
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K885203 · Technicon Instruments Corp. · Mar 1989
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K871973 · Instrumentation Laboratory CO · Jun 1987