The following data is part of a premarket notification filed by Ascensia Diabetes Care Us Inc with the FDA for Microlet Next Lancing Device, Microlet Lancet.
| Device ID | K220633 |
| 510k Number | K220633 |
| Device Name: | MICROLET NEXT Lancing Device, MICROLET Lancet |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | Ascensia Diabetes Care US Inc 5 Wood Hollow Road Parsippany, NJ 07054 |
| Contact | Sangram Yadav |
| Correspondent | Sangram Yadav Ascensia Diabetes Care US Inc 5 Wood Hollow Road Parsippany, NJ 07054 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301936721013 | K220633 | 000 |
| 40301936705013 | K220633 | 000 |
| 40301936702012 | K220633 | 000 |
| 40301936586124 | K220633 | 000 |