Cleared Traditional

CHLAMYDIA TRACHOMATIS ANTIGEN TEST

K941714 · Neogenex · Microbiology
Jul 1994
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K941714 is an FDA 510(k) clearance for the CHLAMYDIA TRACHOMATIS ANTIGEN TEST, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Neogenex (Everett, US). The FDA issued a Cleared decision on July 18, 1994, 117 days after receiving the submission on March 23, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K941714 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1994
Decision Date July 18, 1994
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LJP — Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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