Cleared Traditional

K834119 - MCCOY CELLS (FDA 510(k) Clearance)

Class I Pathology device.

K834119 · Bartels Immunodiagnostic Supplies, Inc. · Pathology device
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Mar 1984
Decision
114d
Days
Class 1
Risk

K834119 is an FDA 510(k) clearance for the MCCOY CELLS. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1984 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2280 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K834119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1983
Decision Date March 22, 1984
Days to Decision 114 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 77d · This submission: 114d
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.