TDX DISOPYRAMIDE— 510(k) K842713

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K842713 for TDX DISOPYRAMIDE, Substantially Equivalent on 1984-08-29. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LBZ
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1984-07-12
Decision date: 1984-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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