Cleared Traditional

CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST

K864389 · American Micro Scan · Microbiology
Dec 1986
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K864389 is an FDA 510(k) clearance for the CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on December 4, 1986, 28 days after receiving the submission on November 6, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K864389 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1986
Decision Date December 04, 1986
Days to Decision 28 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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