Cleared Traditional

PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST

K900870 · Diagnostic Products Corp. · Microbiology
Apr 1990
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K900870 is an FDA 510(k) clearance for the PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 16, 1990, 51 days after receiving the submission on February 24, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K900870 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1990
Decision Date April 16, 1990
Days to Decision 51 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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