LUTEINIZING HORMONE DIRECT RIA KIT 125/I— 510(k) K811024

Name: FDA 510(k) clearance K811024
Creator: U.S. Food and Drug Administration
Published: 1981-05-08

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K811024 for LUTEINIZING HORMONE DIRECT RIA KIT 125/I, Substantially Equivalent on 1981-05-08. Applicant: Immunalysis Corporation. Device class: 1.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1981-04-15
Decision date: 1981-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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