Cleared Traditional

K830694 - DUPONT PREP TYPE CS EXTRACTION CARTRIDE (FDA 510(k) Clearance)

K830694 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Apr 1983
Decision
32d
Days
-
Risk

K830694 is an FDA 510(k) clearance for the DUPONT PREP TYPE CS EXTRACTION CARTRIDE.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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 K830694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1983
Decision Date April 08, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -