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FDA 510(k)

ONLINE TDM Phenytoin - Free Phenytoin application

K-Number: K230161 · 2023-03-30

ApplicantRoche Diagnostics
Decision Date2023-03-30
Product CodeMOJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONLINE TDM Phenytoin - Free Phenytoin application is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2023-03-30 under approval number K230161. The device is classified under product code MOJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONLINE TDM Phenytoin - Free Phenytoin application?

ONLINE TDM Phenytoin - Free Phenytoin application is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Roche Diagnostics. The 510(k) number is K230161.

When was ONLINE TDM Phenytoin - Free Phenytoin application approved by the FDA?

ONLINE TDM Phenytoin - Free Phenytoin application received FDA 510(k) clearance on 2023-03-30, under approval number K230161.

What company makes ONLINE TDM Phenytoin - Free Phenytoin application?

ONLINE TDM Phenytoin - Free Phenytoin application is manufactured by Roche Diagnostics.

What is the FDA product code for ONLINE TDM Phenytoin - Free Phenytoin application?

The FDA product code for ONLINE TDM Phenytoin - Free Phenytoin application is MOJ.

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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.

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