Cobas® CT/NG V2.0 Test

Dna-reagents, Neisseria

Roche Molecular Systems, Inc.

The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas® Ct/ng V2.0 Test.

Pre-market Notification Details

• Device ID: K163184
• 510k Number: K163184
• Device Name: Cobas® CT/NG V2.0 Test
• Classification: Dna-reagents, Neisseria
• Applicant: Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588
• Contact: David W. Gates
• Correspondent: David W. Gates; Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588
• Product Code: LSL
• Subsequent Product Code: MKZ
• Subsequent Product Code: OOI
• CFR Regulation Number: 866.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-14
• Decision Date: 2017-02-09
• Summary: summary