Cleared Traditional

K841338 - ULTRACLONE ECL-01-600 CELL LINE

K841338 is an FDA 510(k) clearance for ULTRACLONE ECL-01-600 CELL LINE, manufactured by Earl-Clay Laboratories, Inc.. The device is a Class 1 Hematology device with product code KIR cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K841338 · Earl-Clay Laboratories, Inc. · Hematology device
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May 1984
Decision
39d
Days
Class 1
Risk

K841338 is an FDA 510(k) clearance for the ULTRACLONE ECL-01-600 CELL LINE. 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 May 11, 1984 after a review of 39 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

FDA 510(k) Submission Details - K841338

510(k) Number K841338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date May 11, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 113d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

KIR Device Classification - Class 1, General Controls

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.

Regulatory Peers - KIR Cells, Animal And Human, Cultured

All 154
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K841338.
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
WI-38
K841806 · Viromed Laboratories, Inc. · Jun 1984
ULTRACLONE ECL-01-800 CELL LINE
K841337 · Earl-Clay Laboratories, Inc. · May 1984
ULTRA CLONE ECL-01-700 CELL LINE
K841339 · Earl-Clay Laboratories, Inc. · May 1984
ULTRACLONE ECL-01-900 CELL LINE
K841340 · Earl-Clay Laboratories, Inc. · May 1984
ULTRACLONE ECL-01-1000 CELL LINE
K841341 · Earl-Clay Laboratories, Inc. · May 1984