ONLINE TDM Methotrexate— 510(k) K233454
Substantially EquivalentRoche Diagnostics Operations
FDA 510(k) clearance K233454 for ONLINE TDM Methotrexate, Substantially Equivalent on 2024-02-20. Applicant: Roche Diagnostics Operations. Device class: Unclassified.
Clearance details
- Applicant
- Roche Diagnostics Operations
- Product code
- Code LAO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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