K031902
Substantially EquivalentONLINE TDM CARBAMAZEPINE
- Applicant
- Roche Diagnostics Corp.
- Product code
- KLT
- Advisory panel
- Clinical Toxicology
- 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.