FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EUROIMMUN ANTI-ENA POOL ELISA (IGG)
K Number: K112996
·
Decision Apr 9, 2013
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
177
Applicant Total
12
Review Days
550
Basic Information
- Device Name
- EUROIMMUN ANTI-ENA POOL ELISA (IGG)
- K Number
- K112996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EUROIMMUN US
- Date Received
- October 7, 2011
- Decision Date
- April 9, 2013
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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|---|---|---|---|
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