CHEMKIT PHENYTOIN DIAG. KIT— 510(k) K833806

Name: FDA 510(k) clearance K833806
Creator: U.S. Food and Drug Administration
Published: 1984-01-30

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K833806 for CHEMKIT PHENYTOIN DIAG. KIT, Substantially Equivalent on 1984-01-30. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DIP
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1983-11-01
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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