Cleared Traditional

MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT

K871278 · California Integrated Diagnostics, Inc. · Microbiology
Apr 1987
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K871278 is an FDA 510(k) clearance for the MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by California Integrated Diagnostics, Inc. (Berkeley, US). The FDA issued a Cleared decision on April 8, 1987, 8 days after receiving the submission on March 31, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K871278 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1987
Decision Date April 08, 1987
Days to Decision 8 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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