Cleared Traditional

K842549 - ACA ACETAMINOPHEN CALIBRATOR (FDA 510(k) Clearance)

K842549 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Aug 1984
Decision
45d
Days
-
Risk

K842549 is an FDA 510(k) clearance for the ACA ACETAMINOPHEN CALIBRATOR.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1984 after a review of 45 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 K842549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date August 16, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 87d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -