Cleared Traditional

K843864 - ULTRACLONE ECL-01-1400 CELL LINE

K843864 is an FDA 510(k) clearance for ULTRACLONE ECL-01-1400 CELL LINE, manufactured by Earl-Clay Laboratories, Inc.. The device is a Class 1 Pathology device with product code KIT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K843864 · Earl-Clay Laboratories, Inc. · Pathology device
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Oct 1984
Decision
15d
Days
Class 1
Risk

K843864 is an FDA 510(k) clearance for the ULTRACLONE ECL-01-1400 CELL LINE. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Earl-Clay Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1984 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - the FDA pathology 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

FDA 510(k) Submission Details - K843864

510(k) Number K843864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date October 17, 1984
Days to Decision 15 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 77d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

KIT Device Classification - Class 1, General Controls

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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.

Regulatory Peers - KIT Media And Components, Synthetic Cell And Tissue Culture

All 335
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K843864.
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