The following data is part of a premarket notification filed by Suzhou Kyuan Medical Apparatus Co., Ltd. with the FDA for Disposable Blood Lancets.
| Device ID | K220387 |
| 510k Number | K220387 |
| Device Name: | Disposable Blood Lancets |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | Suzhou Kyuan Medical Apparatus Co., Ltd. Beiqiao Town Suzhou, CN |
| Contact | Shi Ye |
| Correspondent | Shi Ye Suzhou Kyuan Medical Apparatus Co., Ltd. Beiqiao Town Suzhou, CN |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-10 |
| Decision Date | 2022-08-17 |