EUROIMMUN ANTI-ENA POOL ELISA (IGG)— 510(k) K112996
Substantially EquivalentEuroimmun US
FDA 510(k) clearance K112996 for EUROIMMUN ANTI-ENA POOL ELISA (IGG), Substantially Equivalent on 2013-04-09. Applicant: Euroimmun US.
Clearance details
- Applicant
- Euroimmun US
- Product code
- Code LLL
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morris Plains, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.