Cleared Traditional

K934973 - HELA-229/HELA CELLS

K934973 is an FDA 510(k) clearance for HELA-229/HELA CELLS, manufactured by Advanced Clinical Diagnostics. The device is a Class 1 Pathology device with 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

FDA 510(k) Submission Details - K934973

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 77d · This submission: 102d
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 K934973.
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KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO
K934240 · Advanced Clinical Diagnostics · Jan 1994