The following data is part of a premarket notification filed by Roche Diabetes Care, Inc. with the FDA for Accu-chek Safe-t-pro Plus Lancing Device.
| Device ID | K220849 |
| 510k Number | K220849 |
| Device Name: | Accu-Chek Safe-T-Pro Plus Lancing Device |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46256 |
| Contact | Jason Lee |
| Correspondent | Jason Lee Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46256 |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-23 |
| Decision Date | 2022-05-19 |