Cleared Traditional

MRC-5 CELL CULTURE VIAL (K952727) - FDA 510(k) Clearance

Class I Microbiology device.

K952727 · Viratest Intl., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.