The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Tv/mg For Use On Cobas 6800/8800 Systems, Cobas Tv/mg Positive Control Kit, Cobas Buffer Negative Control Kit.
| Device ID | K190433 |
| 510k Number | K190433 |
| Device Name: | Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control Kit |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| 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 | QEP |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-22 |
| Decision Date | 2019-05-22 |