Cleared Traditional

K952727 - MRC-5 CELL CULTURE VIAL

K952727 is an FDA 510(k) clearance for MRC-5 CELL CULTURE VIAL, manufactured by Viratest Intl., Inc.. The device is a Class 1 Microbiology device with product code KIR cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K952727 · Viratest Intl., Inc. · Microbiology device
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Nov 1995
Decision
159d
Days
Class 1
Risk

K952727 is an FDA 510(k) clearance for the MRC-5 CELL CULTURE VIAL. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Viratest Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 159 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2280 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Viratest Intl., Inc. devices

FDA 510(k) Submission Details - K952727

510(k) Number K952727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1995
Decision Date November 20, 1995
Days to Decision 159 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 102d · This submission: 159d
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 155
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K952727.
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
K951440 · Viromed Laboratories, Inc. · May 1996
NCI-H292 CELL CULTURE
K951461 · Viromed Laboratories, Inc. · May 1996
A549 CELL CULTURE
K955921 · Viratest Intl., Inc. · Feb 1996
PRIMARY MONKEY KIDNEY CELL CULTURE
K943884 · Neogenex · Nov 1994
PRIMARY RABBIT KIDNEY CELL CULTURE
K943885 · Neogenex · Nov 1994
BGM CELL CULTURE
K943886 · Neogenex · Nov 1994