DIGOXIN RADIOIMMUNOASSAY KIT— 510(k) K802841

Name: FDA 510(k) clearance K802841
Creator: U.S. Food and Drug Administration
Published: 1980-12-18

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K802841 for DIGOXIN RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1980-12-18. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code DNL
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1980-11-12
Decision date: 1980-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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