NICHOLS ADVANTAGE ALDOSTERONE ASSAY— 510(k) K032188

Name: FDA 510(k) clearance K032188
Creator: U.S. Food and Drug Administration
Published: 2003-07-31

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K032188 for NICHOLS ADVANTAGE ALDOSTERONE ASSAY, Substantially Equivalent on 2003-07-31. Applicant: Nichols Institute Diagnostics. Device class: 2.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code CJM
Device class: Class 2
Regulation: 21 CFR 862.1045
Advisory panel: Clinical Chemistry
Date received: 2003-07-17
Decision date: 2003-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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