K173887 is an FDA 510(k) clearance for the cobas CT/NG for use on cobas 6800/8800 systems. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K173887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LSL — Dna-reagents, Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |