FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FINDER G6PD
K Number: K201049
·
Decision Sep 14, 2022
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
4
Applicant Total
3
Review Days
876
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Basic Information
- Device Name
- FINDER G6PD
- K Number
- K201049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7360
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baebies, Inc.
- Date Received
- April 21, 2020
- Decision Date
- September 14, 2022
- Product Code
- JBF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | FDA class 2 | Hematology |
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