Cleared Traditional

K934973 - HELA-229/HELA CELLS

K934973 is the FDA 510(k) clearance for HELA-229/HELA CELLS by Advanced Clinical Diagnostics. It is a Class 1 Pathology device (product code KIR) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K934973 · Advanced Clinical Diagnostics · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
102d
Days
Class 1
Risk

K934973 is an FDA 510(k) clearance for the HELA-229/HELA CELLS. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Advanced Clinical Diagnostics (Toledo, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 102 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 Advanced Clinical Diagnostics devices

Submission Details

510(k) Number K934973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date January 28, 1994
Days to Decision 102 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
25d slower than avg
Panel avg: 77d · This submission: 102d
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 80
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K934973.
FRESHFROZEN CELLS, HEP-2
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FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
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FRESH FROZEN CELLS
K940502 · Diagnostic Hybrids, Inc. · Jun 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