DIGOXIN RADIOIMMUNOASSAY— 510(k) K820274

Name: FDA 510(k) clearance K820274
Creator: U.S. Food and Drug Administration
Published: 1982-02-23

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K820274 for DIGOXIN RADIOIMMUNOASSAY, Substantially Equivalent on 1982-02-23. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code DPB
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1982-02-02
Decision date: 1982-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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