The following data is part of a premarket notification filed by Beijing Ruicheng Medical Supplies Co., Ltd. with the FDA for Rightlance Blood Lancing System.
| Device ID | K222034 |
| 510k Number | K222034 |
| Device Name: | RightLance Blood Lancing System |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | Beijing Ruicheng Medical Supplies Co., Ltd. No.13 Yanqi Ave, Yanqi Economic Development Zone, Huairou District Beijing, CN 101400 |
| Contact | Yuechao Li |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-11 |
| Decision Date | 2022-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| MHC17321010 | K222034 | 000 |
| MHC17301010 | K222034 | 000 |
| MHC17080012 | K222034 | 000 |
| 00709334980001 | K222034 | 000 |
| 50709334581210 | K222034 | 000 |