CORTISOL CHEMILUMINESCENCE ASSAY— 510(k) K922676

Name: FDA 510(k) clearance K922676
Creator: U.S. Food and Drug Administration
Published: 1992-07-10

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K922676 for CORTISOL CHEMILUMINESCENCE ASSAY, Substantially Equivalent on 1992-07-10. Applicant: Nichols Institute. Device class: 2.

Clearance details

Applicant: Nichols Institute
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1992-06-04
Decision date: 1992-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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