Cleared Traditional

RD CULTURE CELL

K943891 · Neogenex · Pathology
Nov 1994
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K943891 is an FDA 510(k) clearance for the RD CULTURE CELL, 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 November 28, 1994, 111 days after receiving the submission on August 9, 1994. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K943891 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1994
Decision Date November 28, 1994
Days to Decision 111 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