REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.— 510(k) K874486

Name: FDA 510(k) clearance K874486
Creator: U.S. Food and Drug Administration
Published: 1987-11-23

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K874486 for REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA., Substantially Equivalent on 1987-11-23. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1987-10-30
Decision date: 1987-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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