FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANA SCREEN ELISA (IGG)
K Number: K131185
·
Decision Jul 15, 2013
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
12
Review Days
80
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Basic Information
- Device Name
- ANA SCREEN ELISA (IGG)
- K Number
- K131185
- 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
- April 26, 2013
- Decision Date
- July 15, 2013
- Product Code
- LJM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
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|---|---|---|---|
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