DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT— 510(k) K864449

Name: FDA 510(k) clearance K864449
Creator: U.S. Food and Drug Administration
Published: 1987-02-02

Substantially Equivalent

Canadian Bioclinical, Ltd.

FDA 510(k) clearance K864449 for DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1987-02-02. Applicant: Canadian Bioclinical, Ltd.. Device class: 2.

Clearance details

Applicant: Canadian Bioclinical, Ltd.
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1986-11-12
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario Mix 1b4, CA

Download summary PDF View on FDA.gov ↗

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