The following data is part of a premarket notification filed by Shanghai Carelife International Trading Co. Ltd. with the FDA for Medtfine Blood Lancet.
| Device ID | K221383 |
| 510k Number | K221383 |
| Device Name: | MedtFine Blood Lancet |
| Classification | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Applicant | Shanghai Carelife International Trading Co. Ltd. 1707 Yinqiao Bldg.,58 Jinxin Rd.201206 Shanghai, People's Republic Of China Shanghai, CN 201206 |
| Contact | Zhang Xiaoying |
| Correspondent | Evan Hu Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, CN 201114 |
| Product Code | QRK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-09-21 |