Cleared Traditional

K852204 - MCCOY GENCELLS

K852204 is the FDA 510(k) clearance for MCCOY GENCELLS by Genus Diagnostics. It is a Class 1 Pathology device (product code KIR) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K852204 · Genus Diagnostics · Pathology device
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Jun 1985
Decision
14d
Days
Class 1
Risk

K852204 is an FDA 510(k) clearance for the MCCOY GENCELLS. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Genus Diagnostics (Woburn, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 14 days - a notably fast clearance cycle.

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: 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 Genus Diagnostics devices

Submission Details

510(k) Number K852204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1985
Decision Date June 04, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 77d · This submission: 14d
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 80
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K852204.
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776 · Bartels Immunodiagnostic Supplies, Inc. · Dec 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
K860292 · Difco Laboratories, Inc. · Feb 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
K860293 · Difco Laboratories, Inc. · Feb 1986
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366 · Difco Laboratories, Inc. · Jan 1985
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL
K841998 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999 · Bartels Immunodiagnostic Supplies, Inc. · Jun 1984