MAGIC 125I DIGOXIN RADIOIMMUNOASSAY— 510(k) K840461

Name: FDA 510(k) clearance K840461
Creator: U.S. Food and Drug Administration
Published: 1984-03-23

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K840461 for MAGIC 125I DIGOXIN RADIOIMMUNOASSAY, Substantially Equivalent on 1984-03-23. Applicant: Corning Medical & Scientific. Device class: 2.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1984-02-02
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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