ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE— 510(k) K922991

Name: FDA 510(k) clearance K922991
Creator: U.S. Food and Drug Administration
Published: 1992-08-27

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K922991 for ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE, Substantially Equivalent on 1992-08-27. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LGS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1992-06-22
Decision date: 1992-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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