RIANEN ESTRIOL RADIOIMMUNOASSAY KIT— 510(k) K840301

Name: FDA 510(k) clearance K840301
Creator: U.S. Food and Drug Administration
Published: 1984-03-30

Substantially Equivalent

New England Nuclear

FDA 510(k) clearance K840301 for RIANEN ESTRIOL RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1984-03-30. Applicant: New England Nuclear. Device class: 1.

Clearance details

Applicant: New England Nuclear
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1984-01-24
Decision date: 1984-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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