Cleared Traditional

K940502 - FRESH FROZEN CELLS

K940502 is the FDA 510(k) clearance for FRESH FROZEN CELLS by Diagnostic Hybrids, Inc.. It is a Class 1 Pathology device (product code KIR) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K940502 · Diagnostic Hybrids, Inc. · Pathology device
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Jun 1994
Decision
134d
Days
Class 1
Risk

K940502 is an FDA 510(k) clearance for the FRESH FROZEN CELLS. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on June 16, 1994 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Hybrids, Inc. devices

Submission Details

510(k) Number K940502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1994
Decision Date June 16, 1994
Days to Decision 134 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 77d · This submission: 134d
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.

Regulatory Peers - KIR Cells, Animal And Human, Cultured

All 79
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K940502.
FRESHCELLS, HEP-2
K962780 · Diagnostic Hybrids, Inc. · Aug 1996
FRESHFROZEN CELLS, HEP-2
K962782 · Diagnostic Hybrids, Inc. · Aug 1996
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
K936271 · Diagnostic Hybrids, Inc. · Aug 1994
25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291
K930390 · Proteins Intl., Inc. · Mar 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261
K930391 · Proteins Intl., Inc. · Mar 1993
16 X 125 MM TEST TUBE, CATALOG #01-111
K930392 · Proteins Intl., Inc. · Mar 1993