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FDA 510(k)

TDX(R)/TDXFLX(R) FREE PHENYTOIN II

K-Number: K950280 · 1995-05-02

ApplicantAbbott Laboratories
Decision Date1995-05-02
Product CodeMOJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX(R)/TDXFLX(R) FREE PHENYTOIN II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K950280. 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 TDX(R)/TDXFLX(R) FREE PHENYTOIN II?

TDX(R)/TDXFLX(R) FREE PHENYTOIN II is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Abbott Laboratories. The 510(k) number is K950280.

When did TDX(R)/TDXFLX(R) FREE PHENYTOIN II receive FDA 510(k) clearance?

TDX(R)/TDXFLX(R) FREE PHENYTOIN II received FDA 510(k) clearance on 1995-05-02, under 510(k) number K950280.

Who is the listed applicant for TDX(R)/TDXFLX(R) FREE PHENYTOIN II?

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

What is the FDA product code for TDX(R)/TDXFLX(R) FREE PHENYTOIN II?

The FDA product code for TDX(R)/TDXFLX(R) FREE PHENYTOIN II is MOJ.

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Related Devices (Code: 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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