ONLINE TDM Methotrexate
K-Number: K233454 · 2024-02-20
ApplicantRoche Diagnostics Operations
Decision Date2024-02-20
Product CodeLAO
DecisionSubstantially Equivalent
Device Summary
ONLINE TDM Methotrexate is a medical device manufactured by Roche Diagnostics Operations. It received FDA 510(k) clearance on 2024-02-20 under approval number K233454. The device is classified under product code LAO. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ONLINE TDM Methotrexate?
ONLINE TDM Methotrexate is a medical device that received FDA 510(k) clearance on 2024-02-20. It is manufactured by Roche Diagnostics Operations. The 510(k) number is K233454.
When was ONLINE TDM Methotrexate approved by the FDA?
ONLINE TDM Methotrexate received FDA 510(k) clearance on 2024-02-20, under approval number K233454.
What company makes ONLINE TDM Methotrexate?
ONLINE TDM Methotrexate is manufactured by Roche Diagnostics Operations.
What is the FDA product code for ONLINE TDM Methotrexate?
The FDA product code for ONLINE TDM Methotrexate is LAO.
Other Devices by Roche Diagnostics Operations
Related Devices (Code: LAO)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.