The following data is part of a premarket notification filed by Roche Diagnostics Hematology, Inc. with the FDA for Cobas M 511 Integrated Hematology Analyzer.
| Device ID | K171655 |
| 510k Number | K171655 |
| Device Name: | Cobas M 511 Integrated Hematology Analyzer |
| Classification | Counter, Differential Cell |
| Applicant | Roche Diagnostics Hematology, Inc. 69 Milk Street, Suite 120 Westborough, MA 01581 |
| Contact | Dan Bracco |
| Correspondent | Dan Bracco Roche Diagnostics Hematology, Inc. 69 Milk Street, Suite 120 Westborough, MA 01581 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2018-03-02 |
| Summary: | summary |