ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET— 510(k) K103716
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K103716 for ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET, Substantially Equivalent on 2011-05-12. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CGN
- Advisory panel
- Clinical Chemistry
- 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.