Cleared Traditional

K936271 - FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE

K936271 is an FDA 510(k) clearance for FRESH CELLS MULTI-WELL PLATE CULTURES A..., manufactured by Diagnostic Hybrids, Inc.. The device is a Class 1 Pathology device with product code KIR cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K936271 · Diagnostic Hybrids, Inc. · Pathology device
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Aug 1994
Decision
239d
Days
Class 1
Risk

K936271 is an FDA 510(k) clearance for the FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE. 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 August 26, 1994 after a review of 239 days - an extended review cycle.

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

FDA 510(k) Submission Details - K936271

510(k) Number K936271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date August 26, 1994
Days to Decision 239 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
162d slower than avg
Panel avg: 77d · This submission: 239d
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 K936271.
VERO CELL CULTURE
K943889 · Neogenex · Nov 1994
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K943890 · Neogenex · Nov 1994
RD CULTURE CELL
K943891 · Neogenex · Nov 1994
FRESH FROZEN CELLS
K940502 · Diagnostic Hybrids, Inc. · Jun 1994
HEP-2 CULTURE CELL
K933927 · Neogenex · Mar 1994
A549 CULTURE CELL
K933923 · Neogenex · Mar 1994