The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Ct/ng For Use On Cobas 6800/8800 Systems.
| Device ID | K173887 |
| 510k Number | K173887 |
| Device Name: | Cobas CT/NG For Use On Cobas 6800/8800 Systems |
| Classification | Dna-reagents, Neisseria |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Nobuko Nakajima |
| Correspondent | Nobuko Nakajima Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| 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 | 2017-12-21 |
| Decision Date | 2018-03-21 |
| Summary: | summary |