AXSYM AMPHETAMINE/METHAMPHETAMINE II— 510(k) K953115

Name: FDA 510(k) clearance K953115
Creator: U.S. Food and Drug Administration
Published: 1995-10-06

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K953115 for AXSYM AMPHETAMINE/METHAMPHETAMINE II, Substantially Equivalent on 1995-10-06. 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: 1995-07-03
Decision date: 1995-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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