NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY— 510(k) K950524

Name: FDA 510(k) clearance K950524
Creator: U.S. Food and Drug Administration
Published: 1995-05-15

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K950524 for NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY, Substantially Equivalent on 1995-05-15. Applicant: Nichols Institute. Device class: 1.

Clearance details

Applicant: Nichols Institute
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1995-01-30
Decision date: 1995-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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