TDX(R)/TDXFLX(R) FREE PHENYTOIN II— 510(k) K950280

Name: FDA 510(k) clearance K950280
Creator: U.S. Food and Drug Administration
Published: 1995-05-02

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K950280 for TDX(R)/TDXFLX(R) FREE PHENYTOIN II, Substantially Equivalent on 1995-05-02. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code MOJ
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1995-01-24
Decision date: 1995-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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