Cleared Traditional

SDI PREPAX DILUKIT 29-1000 (K840044) - FDA 510(k) Clearance

Class I Toxicology device.

K840044 · Scientific Distributors, Inc. · Toxicology device
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Mar 1984
Decision
63d
Days
Class 1
Risk

K840044 is an FDA 510(k) clearance for the SDI PREPAX DILUKIT 29-1000. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Scientific Distributors, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2540 - 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 Scientific Distributors, Inc. devices

Submission Details

510(k) Number K840044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date March 09, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
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.