The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System.
| Device ID | K171770 |
| 510k Number | K171770 |
| Device Name: | Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-14 |
| Decision Date | 2017-09-12 |
| Summary: | summary |