Cleared Traditional

K920942 - OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER

K920942 is an FDA 510(k) clearance for OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER, manufactured by Olympus Corp.. The device is a Class 1 Chemistry device with product code JJG cleared through the Traditional 510(k) pathway after a 104-day FDA review.

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

FDA 510(k) Submission Details - K920942

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.

JJG Device Classification - Class 1, General Controls

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 22
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