Cleared Traditional

LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE (K884403) - FDA 510(k) Clearance

Class I Toxicology device.

K884403 · Supelco, Inc. · Toxicology device
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Dec 1988
Decision
64d
Days
Class 1
Risk

K884403 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE. Classified as Columns, Liquid Chromatography (product code DPM), Class I - General Controls.

Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Supelco, Inc. devices

Submission Details

510(k) Number K884403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1988
Decision Date December 22, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 87d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DPM Columns, Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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.