The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Influenza A/b Nucleic Acid Test For Use On The Cobas Liat System, Cobas Influenza A/b & Rsv Nucleic Acid Test For Use On The Cobas Liat System, Cobas Strep A Nucleic Acid Test For Use On The Cobas Liat System.
| Device ID | K200065 |
| 510k Number | K200065 |
| Device Name: | Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System, Cobas Influenza A/B & RSV Nucleic Acid Test For Use On The Cobas Liat System, Cobas Strep A Nucleic Acid Test For Use On The Cobas Liat System |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Kaitlyn Hameister |
| Correspondent | Kaitlyn Hameister Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Product Code | OCC |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OZE |
| Subsequent Product Code | PGX |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-02-10 |