The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Hcv.
| Device ID | K221007 |
| 510k Number | K221007 |
| Device Name: | Cobas HCV |
| Classification | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Ashley Malich |
| Correspondent | Ashley Malich Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Product Code | MZP |
| CFR Regulation Number | 866.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-05 |
| Decision Date | 2022-11-04 |