Cleared Traditional

MODIFIED CHLAMYSET ANTIGEN

K872744 · Orion Corp. · Microbiology
Sep 1987
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K872744 is an FDA 510(k) clearance for the MODIFIED 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 September 22, 1987, 74 days after receiving the submission on July 10, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K872744 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1987
Decision Date September 22, 1987
Days to Decision 74 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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