ANA SCREEN ELISA (IGG)— 510(k) K131185
Substantially EquivalentEuroimmun US
FDA 510(k) clearance K131185 for ANA SCREEN ELISA (IGG), Substantially Equivalent on 2013-07-15. Applicant: Euroimmun US. Device class: 2.
Clearance details
- Applicant
- Euroimmun US
- Product code
- Code LJM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morris Plains, NJ, US
Recent devices under product code LJM
view allMore clearances from Euroimmun US
view allData sourced from openFDA. This site is unofficial and independent of the FDA.