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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-03-30 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K230161.

When did ONLINE TDM Phenytoin - Free Phenytoin application receive FDA 510(k) clearance?

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

Who is the listed applicant for ONLINE TDM Phenytoin - Free Phenytoin application?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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