Cleared Traditional

K951329 - IMMUCHEM GAL-MW EA

K951329 is an FDA 510(k) clearance for IMMUCHEM GAL-MW EA, manufactured by Icn Pharmaceuticals, Inc.. The device is a Class 1 Chemistry device with product code JIA cleared through the Traditional 510(k) pathway after a 231-day FDA review.

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

FDA 510(k) Submission Details - K951329

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

JIA Device Classification - Class 1, General Controls

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.