The following data is part of a premarket notification filed by Roche Diagnostics Operations with the FDA for Cobas Hba1c Test, Cobas B 101 System.
| Device ID | K163633 |
| 510k Number | K163633 |
| Device Name: | Cobas HbA1c Test, Cobas B 101 System |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Roche Diagnostics Operations 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Patty Bates |
| Correspondent | Patty Bates Roche Diagnostics Operations 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-07-28 |
| Summary: | summary |