The following data is part of a premarket notification filed by Trividia Health with the FDA for Truedraw Lancing Device, Mini Lancing Device.
| Device ID | K221072 |
| 510k Number | K221072 |
| Device Name: | TRUEdraw Lancing Device, Mini Lancing Device |
| Classification | Multiple Use Blood Lancet For Single Patient Use Only |
| Applicant | Trividia Health 2400 N.W. 55th Court Fort Lauderdale, FL 33309 |
| Contact | Jacqueline Davis |
| Correspondent | Jacqueline Davis Trividia Health 2400 N.W. 55th Court Fort Lauderdale, FL 33309 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-12 |
| Decision Date | 2022-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10087701526203 | K221072 | 000 |
| 10052569138424 | K221072 | 000 |
| 10050428645946 | K221072 | 000 |
| 10021292142015 | K221072 | 000 |
| 10011822741085 | K221072 | 000 |
| 10010939709445 | K221072 | 000 |
| 10010939958683 | K221072 | 000 |