FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K Number: K143483
·
Decision Jan 8, 2015
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
28
Applicant Total
32
Review Days
31
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Basic Information
- Device Name
- MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
- K Number
- K143483
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sebia
- Date Received
- December 8, 2014
- Decision Date
- January 8, 2015
- Product Code
- CFF
- 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 |
|---|---|---|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | FDA class 2 | Immunology |
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