Cleared Traditional

K955608 - MCCOY CELL CULTURES

K955608 is an FDA 510(k) clearance for MCCOY CELL CULTURES, manufactured by Vai Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code KIR cleared through the Traditional 510(k) pathway after a 213-day FDA review.

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

FDA 510(k) Submission Details - K955608

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 102d · This submission: 213d
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 154
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K955608.
FRESHFROZENCELLS
K962311 · Diagnostic Hybrids, Inc. · Aug 1996
FRESHCELLS, HEP-2
K962780 · Diagnostic Hybrids, Inc. · Aug 1996
FRESHFROZEN CELLS, HEP-2
K962782 · Diagnostic Hybrids, Inc. · Aug 1996
H292 CELL CULTURE
K960909 · Neogenex · May 1996
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
K951440 · Viromed Laboratories, Inc. · May 1996
NCI-H292 CELL CULTURE
K951461 · Viromed Laboratories, Inc. · May 1996