The following data is part of a premarket notification filed by Baebies, Inc. with the FDA for Finder G6pd.
| Device ID | K201049 |
| 510k Number | K201049 |
| Device Name: | FINDER G6PD |
| Classification | Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening |
| Applicant | Baebies, Inc. 615 Davis Drive Suite 800 Morrisville, NC 27560 |
| Contact | Ailen Gillette |
| Correspondent | Candice Prowse Baebies, Inc. 25 Alexandria Way Durham, NC 27703 |
| Product Code | JBF |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2022-09-14 |