BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.— 510(k) K821347

Name: FDA 510(k) clearance K821347
Creator: U.S. Food and Drug Administration
Published: 1982-05-28

Substantially Equivalent

Bioclinical Corp.

FDA 510(k) clearance K821347 for BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN., Substantially Equivalent on 1982-05-28. Applicant: Bioclinical Corp.. Device class: 2.

Clearance details

Applicant: Bioclinical Corp.
Product code: Code LCA
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1982-05-05
Decision date: 1982-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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