Finder G6PD
510(k) K201049
Finder G6PD is a Class II device made by Baebies, Inc., cleared under FDA 510(k) K201049 on 14 Sep 2022, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201049 | Date14 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K201049
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JBF
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7360
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201049
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| FINDER | 110-000014 | 00819704020364 | On the market | |
| FINDER 100-000009 | 100-000009 | 00819704020340 | On the market | |
| FINDER 3409 | 3409 | 00819704020333 | On the market | |
| FINDER Cleaning Accessory 100-000031 | 100-000031 / 100-000031 | 00819704020616 | On the market |
Similar devices
Other devices filed under FDA product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening).