Cleared Traditional

H292 CELL CULTURE

K960909 · Neogenex · Microbiology
May 1996
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K960909 is an FDA 510(k) clearance for the H292 CELL CULTURE, 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 May 30, 1996, 86 days after receiving the submission on March 5, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.2280.

Submission Details

510(k) Number K960909 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1996
Decision Date May 30, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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