Cleared Traditional

K843579 - ULTRACLONE ECL-01-1100 (FDA 510(k) Clearance)

Class I Hematology device.

K843579 · Earl-Clay Laboratories, Inc. · Hematology device
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Oct 1984
Decision
50d
Days
Class 1
Risk

K843579 is an FDA 510(k) clearance for the ULTRACLONE ECL-01-1100. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Earl-Clay Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1984 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.2280 - the FDA hematology 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 Earl-Clay Laboratories, Inc. devices

Submission Details

510(k) Number K843579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1984
Decision Date October 31, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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.