ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01— 510(k) K061165
Substantially EquivalentSweden Diagnostics (Us), Inc.
FDA 510(k) clearance K061165 for ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01, Substantially Equivalent on 2006-08-03. Applicant: Sweden Diagnostics (Us), Inc..
Clearance details
- Applicant
- Sweden Diagnostics (Us), Inc.
- Product code
- Code NHX
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.