BLHI LUTEINIZING HORMONE— 510(k) K851332

Substantially Equivalent

Euro-Diagnostics BV

FDA 510(k) clearance K851332 for BLHI LUTEINIZING HORMONE, Substantially Equivalent on 1985-07-09. Applicant: Euro-Diagnostics BV. Device class: 1.

Clearance details

Applicant: Euro-Diagnostics BV
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1985-04-04
Decision date: 1985-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Old Greenwich, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Euro-Diagnostics BV

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K843930 — IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I1984-10-30
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