Cleared Traditional

K934934 - RABBIT KIDNEY CELLS - R.K.C.

K934934 is an FDA 510(k) clearance for RABBIT KIDNEY CELLS - R.K.C., 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 155-day FDA review.

K934934 · Advanced Clinical Diagnostics · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
155d
Days
Class 1
Risk

K934934 is an FDA 510(k) clearance for the RABBIT KIDNEY CELLS - R.K.C.. 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 155 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 Advanced Clinical Diagnostics devices

FDA 510(k) Submission Details - K934934

510(k) Number K934934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date January 28, 1994
Days to Decision 155 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
78d slower than avg
Panel avg: 77d · This submission: 155d
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 K934934.
RHESUS MONKEY KIDNEY CELLS
K936169 · Advanced Clinical Diagnostics · Feb 1994
TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
K936171 · Advanced Clinical Diagnostics · Feb 1994
RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
K936172 · Advanced Clinical Diagnostics · Feb 1994
HELA-229/HELA CELLS
K934973 · Advanced Clinical Diagnostics · Jan 1994
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
K935766 · Advanced Clinical Diagnostics · Jan 1994
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
K934239 · Advanced Clinical Diagnostics · Jan 1994