PROLACTIN IRMA— 510(k) K842478

Substantially Equivalent

Euro-Diagnostics BV

FDA 510(k) clearance K842478 for PROLACTIN IRMA, Substantially Equivalent on 1984-09-14. Applicant: Euro-Diagnostics BV. Device class: 1.

Clearance details

Applicant: Euro-Diagnostics BV
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1984-06-25
Decision date: 1984-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Euro-Diagnostics BV

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K850053 — BACI 6 -ADRENOCORTICOTROOP HORMONE1985-04-08
K843930 — IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I1984-10-30

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