FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
Quantia IgE
K Number: K214068
·
Decision Feb 21, 2023
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
23
Review Days
421
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Basic Information
- Device Name
- Quantia IgE
- K Number
- K214068
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biokit, S.A.
- Date Received
- December 27, 2021
- Decision Date
- February 21, 2023
- Product Code
- DGC
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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