LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT— 510(k) K803278

Name: FDA 510(k) clearance K803278
Creator: U.S. Food and Drug Administration
Published: 1981-01-21

Substantially Equivalent

Immuno Nuclear Corp.

FDA 510(k) clearance K803278 for LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1981-01-21. Applicant: Immuno Nuclear Corp.. Device class: 1.

Clearance details

Applicant: Immuno Nuclear Corp.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1980-12-29
Decision date: 1981-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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