Cleared Traditional

CHROMATOGRAPHY KIT (K884176) - FDA 510(k) Clearance

Class I Toxicology device.

K884176 · Gelman Sciences, Inc. · Toxicology device
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Apr 1989
Decision
182d
Days
Class 1
Risk

K884176 is an FDA 510(k) clearance for the CHROMATOGRAPHY KIT. Classified as Apparatus, General Use, Thin Layer Chromatography (product code DPA), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on April 4, 1989 after a review of 182 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2270 - 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.

View all Gelman Sciences, Inc. devices

Submission Details

510(k) Number K884176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date April 04, 1989
Days to Decision 182 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 87d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DPA Apparatus, General Use, Thin Layer Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2270
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.