RADIOIMMUNOASSAY LUTEINIZING HORMONE— 510(k) K811994

Name: FDA 510(k) clearance K811994
Creator: U.S. Food and Drug Administration
Published: 1981-07-27

Substantially Equivalent

Endocrine-Metabolic Center

FDA 510(k) clearance K811994 for RADIOIMMUNOASSAY LUTEINIZING HORMONE, Substantially Equivalent on 1981-07-27. Applicant: Endocrine-Metabolic Center. Device class: 1.

Clearance details

Applicant: Endocrine-Metabolic Center
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1981-07-14
Decision date: 1981-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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