K110313
Substantially EquivalentTINA-QUANT HBA1C GEN.2
- Applicant
- Roche Diagnostics
- Product code
- LCP
- Advisory panel
- Hematology
- 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.