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FDA 510(k)

ROCHE ONLINE TDM PHENYTOIN

K-Number: K030428 · 2003-04-28

ApplicantRoche Diagnostics Corp.
Decision Date2003-04-28
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE ONLINE TDM PHENYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-04-28 under 510(k) number K030428. The device is classified under product code DIP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE ONLINE TDM PHENYTOIN?

ROCHE ONLINE TDM PHENYTOIN is a medical device that received FDA 510(k) clearance on 2003-04-28. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K030428.

When did ROCHE ONLINE TDM PHENYTOIN receive FDA 510(k) clearance?

ROCHE ONLINE TDM PHENYTOIN received FDA 510(k) clearance on 2003-04-28, under 510(k) number K030428.

Who is the listed applicant for ROCHE ONLINE TDM PHENYTOIN?

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

What is the FDA product code for ROCHE ONLINE TDM PHENYTOIN?

The FDA product code for ROCHE ONLINE TDM PHENYTOIN is DIP.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: DIP)

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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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