Cleared Traditional

CHLAMYSET ANTIGEN

K853401 · Orion Corp. · Microbiology
Apr 1986
Decision
259d
Days
Class 1
Risk

About This 510(k) Submission

K853401 is an FDA 510(k) clearance for the CHLAMYSET ANTIGEN, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on April 28, 1986, 259 days after receiving the submission on August 12, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K853401 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1985
Decision Date April 28, 1986
Days to Decision 259 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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