Cleared Traditional

K861373 - HUMAN LUNG CARCINOMA CELLS (A549)

K861373 is the FDA 510(k) clearance for HUMAN LUNG CARCINOMA CELLS (A549) by Viromed Laboratories, Inc.. It is a Class 1 Pathology device (product code KIR) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K861373 · Viromed Laboratories, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
7d
Days
Class 1
Risk

K861373 is an FDA 510(k) clearance for the HUMAN LUNG CARCINOMA CELLS (A549). Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Viromed Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 18, 1986 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Viromed Laboratories, Inc. devices

Submission Details

510(k) Number K861373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1986
Decision Date April 18, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 77d · This submission: 7d
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 K861373.
BARTELS EXTRACELLULAR MATRIX
K902726 · Baxter Healthcare Corp · Sep 1990
MADIN-DARBY CANINE KIDNEY CULTURE CELLS
K896846 · Baxter Healthcare Corp · Feb 1990
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776 · Bartels Immunodiagnostic Supplies, Inc. · Dec 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
K860292 · Difco Laboratories, Inc. · Feb 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
K860293 · Difco Laboratories, Inc. · Feb 1986
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366 · Difco Laboratories, Inc. · Jan 1985