Cleared Traditional

cobas CT/NG for use on cobas 6800/8800 systems

K173887 · Roche Molecular Systems, Inc. · Microbiology
Mar 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K173887 is an FDA 510(k) clearance for the cobas CT/NG for use on cobas 6800/8800 systems, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on March 21, 2018, 90 days after receiving the submission on December 21, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K173887 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2017
Decision Date March 21, 2018
Days to Decision 90 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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