Cleared Traditional

CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS

K864662 · American Micro Scan · Microbiology
Mar 1987
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K864662 is an FDA 510(k) clearance for the CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS, 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 March 25, 1987, 117 days after receiving the submission on November 28, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K864662 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1986
Decision Date March 25, 1987
Days to Decision 117 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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