IBL CORTISOL LIA TEST KIT— 510(k) K052359

Name: FDA 510(k) clearance K052359
Creator: U.S. Food and Drug Administration
Published: 2005-10-03

Substantially Equivalent

Lehnus & Associates Consulting

FDA 510(k) clearance K052359 for IBL CORTISOL LIA TEST KIT, Substantially Equivalent on 2005-10-03. Applicant: Lehnus & Associates Consulting. Device class: 2.

Clearance details

Applicant: Lehnus & Associates Consulting
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2005-08-26
Decision date: 2005-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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