Cleared Traditional

K823697 - PREP TYPE A EXTRACTION CARTRIDGE (FDA 510(k) Clearance)

Class I Toxicology device.

K823697 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Jan 1983
Decision
27d
Days
Class 1
Risk

K823697 is an FDA 510(k) clearance for the PREP TYPE A EXTRACTION CARTRIDGE. Classified as Ion-exchange Chromatography (product code DJY), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2230 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K823697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1982
Decision Date January 05, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 87d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DJY Ion-exchange Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2230
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.