Cleared Traditional

cobas? CT/NG v2.0 Test

K163184 · Roche Molecular Systems, Inc. · Microbiology
Feb 2017
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K163184 is an FDA 510(k) clearance for the cobas? CT/NG v2.0 Test, 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 February 9, 2017, 87 days after receiving the submission on November 14, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K163184 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2016
Decision Date February 09, 2017
Days to Decision 87 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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