Cleared Traditional

K944731 - ABBOTT IMX 2 ANALYZER (FDA 510(k) Clearance)

Class I Toxicology device.

K944731 · Abbott Laboratories · Toxicology device
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Dec 1994
Decision
98d
Days
Class 1
Risk

K944731 is an FDA 510(k) clearance for the ABBOTT IMX 2 ANALYZER. Classified as Analyzer, Enzyme, For Clinical Use (product code JJI), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 19, 1994 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2500 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K944731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date December 19, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 87d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJI Analyzer, Enzyme, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2500
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.