Cleared Traditional

LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE

K951440 · Viromed Laboratories, Inc. · Pathology
May 1996
Decision
420d
Days
Class 1
Risk

About This 510(k) Submission

K951440 is an FDA 510(k) clearance for the LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE, 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, 420 days after receiving the submission on March 29, 1995. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K951440 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1995
Decision Date May 22, 1996
Days to Decision 420 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code KIR — Cells, Animal And Human, Cultured
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2280