Cleared Traditional

K834119 - MCCOY CELLS

K834119 is the FDA 510(k) clearance for MCCOY CELLS by Bartels Immunodiagnostic Supplies, Inc.. It is a Class 1 Pathology device (product code KIR) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - KIR Cells, Animal And Human, Cultured

All 79
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K834119.
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN
K834117 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
LLC-MK2-RHESUS MONKEY KIDNEY CELLS
K834120 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
WI-38 HUMAN LUNG CELLS
K834123 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984
VERO CELLS
K834124 · Bartels Immunodiagnostic Supplies, Inc. · Mar 1984