NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY— 510(k) K984186

Name: FDA 510(k) clearance K984186
Creator: U.S. Food and Drug Administration
Published: 1999-02-02

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K984186 for NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY, Substantially Equivalent on 1999-02-02. Applicant: Nichols Institute Diagnostics. Device class: 2.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1998-11-23
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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