ELECSYS IGE II IMMUNOASSAY— 510(k) K061970
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K061970 for ELECSYS IGE II IMMUNOASSAY, Substantially Equivalent on 2006-08-31. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code JHR
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.