ETHANOL CONTROLS LOW & HIGH E5133/E5258— 510(k) K843872

Name: FDA 510(k) clearance K843872
Creator: U.S. Food and Drug Administration
Published: 1984-10-31

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K843872 for ETHANOL CONTROLS LOW & HIGH E5133/E5258, Substantially Equivalent on 1984-10-31. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code DKC
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1984-10-02
Decision date: 1984-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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