Cleared Traditional

DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT

K063675 · Diagnostic Hybrids, Inc. · Microbiology
Sep 2007
Decision
287d
Days
Class 1
Risk

About This 510(k) Submission

K063675 is an FDA 510(k) clearance for the DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 24, 2007, 287 days after receiving the submission on December 11, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K063675 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2006
Decision Date September 24, 2007
Days to Decision 287 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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