ORGENTEC RHEUMATOID FACTOR EIA— 510(k) K100499
Substantially EquivalentOrgentec Diagnostika GmbH
FDA 510(k) clearance K100499 for ORGENTEC RHEUMATOID FACTOR EIA, Substantially Equivalent on 2010-10-27. Applicant: Orgentec Diagnostika GmbH.
Clearance details
- Applicant
- Orgentec Diagnostika GmbH
- Product code
- Code DHR
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Stroudsburg, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.