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 |