Cleared Traditional

MCCOY CELL CULTURES (K955608) - FDA 510(k) Clearance

Class I Microbiology device.

K955608 · Vai Diagnostics, Inc. · Microbiology device
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Jul 1996
Decision
213d
Days
Class 1
Risk

K955608 is an FDA 510(k) clearance for the MCCOY CELL CULTURES. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Vai Diagnostics, Inc. (Memphis, US). The FDA issued a Cleared decision on July 8, 1996 after a review of 213 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 Vai Diagnostics, Inc. devices

Submission Details

510(k) Number K955608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1995
Decision Date July 08, 1996
Days to Decision 213 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
111d slower than avg
Panel avg: 102d · This submission: 213d
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.