Cleared Traditional

K934242 - BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.

K934242 is an FDA 510(k) clearance for BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K., 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 130-day FDA review.

K934242 · Advanced Clinical Diagnostics · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
130d
Days
Class 1
Risk

K934242 is an FDA 510(k) clearance for the BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.. 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 3, 1994 after a review of 130 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 - K934242

510(k) Number K934242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date January 03, 1994
Days to Decision 130 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
53d slower than avg
Panel avg: 77d · This submission: 130d
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 K934242.
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
K934239 · Advanced Clinical Diagnostics · Jan 1994
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO
K934240 · Advanced Clinical Diagnostics · Jan 1994
MCCOY CULTURE CELLS-MCCOY
K934241 · Advanced Clinical Diagnostics · Jan 1994
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
K934243 · Advanced Clinical Diagnostics · Jan 1994
HUMAN LUNG DIPLOID CELLS-MRC-5
K934244 · Advanced Clinical Diagnostics · Jan 1994
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.
K934245 · Advanced Clinical Diagnostics · Jan 1994