Cleared Traditional

K951461 - NCI-H292 CELL CULTURE
(FDA 510(k) Clearance)

K951461 · Viromed Laboratories, Inc. · Pathology device

May 1996

Decision

419d

Days

Class 1

Risk

K951461 is an FDA 510(k) clearance for the NCI-H292 CELL CULTURE. This device is classified as a Cells, Animal And Human, Cultured (Class I - General Controls, product code KIR).

Submitted by Viromed Laboratories, Inc. (Minnetonka, US). The FDA issued a Cleared decision on May 22, 1996, 419 days after receiving the submission on March 30, 1995.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number	K951461 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 1995
Decision Date	May 22, 1996
Days to Decision	419 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Statement