510(k) K163184
K163184 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas® CT/NG v2.0 Test". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2017
- Date Received
- November 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Reagents, Neisseria
- Device Class
- Class II
- Regulation Number
- 866.3390
- Review Panel
- MI
- Submission Type