FINDER G6PD— 510(k) K201049
Substantially EquivalentBaebies, Inc.
FDA 510(k) clearance K201049 for FINDER G6PD, Substantially Equivalent on 2022-09-14. Applicant: Baebies, Inc.. Device class: 2.
Clearance details
- Applicant
- Baebies, Inc.
- Product code
- Code JBF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7360
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
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