510(k) K072393— ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
Substantially EquivalentPhadia US, Inc.
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Code LSW
- 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.