The following data is part of a premarket notification filed by Roche Diabetes Care, Inc. with the FDA for Accu-chek Softclix Blood Lancing System.
| Device ID | K214022 |
| 510k Number | K214022 |
| Device Name: | Accu-Chek Softclix Blood Lancing System |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Cameron Smith |
| Correspondent | Cameron Smith Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-22 |
| Decision Date | 2022-02-17 |