The following data is part of a premarket notification filed by Roche Diabetes Care, Inc with the FDA for Accu-chek Fastclix Blood Lancing System.
| Device ID | K220608 |
| 510k Number | K220608 |
| Device Name: | Accu-Chek FastClix 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 | Thomas Kristen |
| Correspondent | Thomas Kristen 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 | 2022-03-02 |
| Decision Date | 2022-04-29 |