Cleared Traditional

K833385 - N-ACETYLPROCAINAMIDE CALIBRATOR (FDA 510(k) Clearance)

Class I Toxicology device.

K833385 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1983
Decision
78d
Days
Class 1
Risk

K833385 is an FDA 510(k) clearance for the N-ACETYLPROCAINAMIDE CALIBRATOR. Classified as Coating, Liquid, Glc (product code DLG), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2250 - 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 K833385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1983
Decision Date December 16, 1983
Days to Decision 78 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 87d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DLG Coating, Liquid, Glc
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2250
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.