FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
AlphaID At Home Genetic Health Risk Service
K Number: K221420
·
Decision Oct 27, 2022
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
4
Applicant Total
4
Review Days
164
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Basic Information
- Device Name
- AlphaID At Home Genetic Health Risk Service
- K Number
- K221420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5950
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Progenika Biopharma S.A., A Grifols Company
- Date Received
- May 16, 2022
- Decision Date
- October 27, 2022
- Product Code
- PTA
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| PTA | Genetic Variant Detection And Health Risk Assessment System | FDA class 2 | Immunology |
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