AXSYM REA ETHANOL— 510(k) K953765

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K953765 for AXSYM REA ETHANOL, Substantially Equivalent on 1995-09-27. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DML
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1995-08-11
Decision date: 1995-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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