Cleared Traditional

K951329 - IMMUCHEM GAL-MW EA (FDA 510(k) Clearance)

Class I Chemistry device.

K951329 · Icn Pharmaceuticals, Inc. · Chemistry device
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Nov 1995
Decision
231d
Days
Class 1
Risk

K951329 is an FDA 510(k) clearance for the IMMUCHEM GAL-MW EA. Classified as Enzymatic Methods, Galactose (product code JIA), Class I - General Controls.

Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 231 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1310 - 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 Icn Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K951329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1995
Decision Date November 09, 1995
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIA Enzymatic Methods, Galactose
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1310
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.