ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01— 510(k) K083117
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K083117 for ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01, Substantially Equivalent on 2009-05-28. Applicant: Phadia US, Inc..
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Code LKO
- 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.