Cleared Traditional

K951440 - LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE (FDA 510(k) Clearance)

Class I Pathology device.

K951440 · Viromed Laboratories, Inc. · Pathology device
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May 1996
Decision
420d
Days
Class 1
Risk

K951440 is an FDA 510(k) clearance for the LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Viromed Laboratories, Inc. (Minnetonka, US). The FDA issued a Cleared decision on May 22, 1996 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Viromed Laboratories, Inc. devices

Submission Details

510(k) Number K951440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1995
Decision Date May 22, 1996
Days to Decision 420 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
343d slower than avg
Panel avg: 77d · This submission: 420d
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.