Cleared Traditional

Xpert CT/NG

K173840 · Cepheid · Microbiology
Mar 2018
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K173840 is an FDA 510(k) clearance for the Xpert CT/NG, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on March 16, 2018, 88 days after receiving the submission on December 18, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K173840 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2017
Decision Date March 16, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSL — Dna-reagents, Neisseria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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