IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I— 510(k) K843930

Name: FDA 510(k) clearance K843930
Creator: U.S. Food and Drug Administration
Published: 1984-10-30

Substantially Equivalent

Euro-Diagnostics BV

FDA 510(k) clearance K843930 for IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I, Substantially Equivalent on 1984-10-30. Applicant: Euro-Diagnostics BV. Device class: 1.

Clearance details

Applicant: Euro-Diagnostics BV
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1984-10-05
Decision date: 1984-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Old Greenwich, CT, US

Download summary PDF View on FDA.gov ↗

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