510(k) K201049
K201049 is an FDA 510(k) premarket notification submitted by Baebies, Inc. for the device "FINDER G6PD". The FDA issued a decision of Substantially Equivalent on September 14, 2022. The device falls under product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening), a Class II device regulated under 21 CFR 864.7360. Baebies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2022
- Date Received
- April 21, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- Device Class
- Class II
- Regulation Number
- 864.7360
- Review Panel
- HE
- Submission Type