The following data is part of a premarket notification filed by Asahi Polyslider Co., Ltd. with the FDA for Onetouch Delica Plus Lancing System.
| Device ID | K221546 |
| 510k Number | K221546 |
| Device Name: | OneTouch Delica Plus Lancing System |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | Asahi Polyslider Co., Ltd. 860-2 Misaki Maniwa, JP 719-3226 |
| Contact | Yoshitaka Akagi |
| Correspondent | Stuart R. Goldman Emergo By UL 2500 Bee Cave Road, Bldg.1 Suite 300 Austin, TX 78746 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-27 |
| Decision Date | 2022-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812608030149 | K221546 | 000 |
| 20812608030051 | K221546 | 000 |
| 00812608030156 | K221546 | 000 |
| 20812608030037 | K221546 | 000 |
| 20812608030020 | K221546 | 000 |
| 00812608030019 | K221546 | 000 |