Cleared Traditional

LLCMK2 CULTURE CELLS

K933926 · Neogenex · Pathology
Mar 1994
Decision
231d
Days
Class 1
Risk

About This 510(k) Submission

K933926 is an FDA 510(k) clearance for the LLCMK2 CULTURE CELLS, a Cells, Animal And Human, Cultured (Class I — General Controls, product code KIR), submitted by Neogenex (Everett, US). The FDA issued a Cleared decision on March 29, 1994, 231 days after receiving the submission on August 10, 1993. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K933926 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1993
Decision Date March 29, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

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