The following data is part of a premarket notification filed by Sterilance Medical (suzhou) Inc. with the FDA for Disposable Blood Lancet.
| Device ID | K221507 |
| 510k Number | K221507 |
| Device Name: | Disposable Blood Lancet |
| Classification | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Applicant | SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou, CN 215153 |
| Contact | Susan Sun |
| Correspondent | Susan Sun SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou, CN 215153 |
| Product Code | QRK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-23 |
| Decision Date | 2022-08-31 |