ELECSYS RUBELLA IGM IMMUNOASSAY— 510(k) K092322
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K092322 for ELECSYS RUBELLA IGM IMMUNOASSAY, Substantially Equivalent on 2010-03-12. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code LFX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.