Cleared Traditional

K936271 - FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE (FDA 510(k) Clearance)

Class I Pathology device.

K936271 · Diagnostic Hybrids, Inc. · Pathology device
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Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 77d · This submission: 239d
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.