ESA PLASMA FREE METANEPHRINE ANALYSIS KIT— 510(k) K032199

Name: FDA 510(k) clearance K032199
Creator: U.S. Food and Drug Administration
Published: 2004-01-30

Substantially Equivalent

Esa, Inc.

FDA 510(k) clearance K032199 for ESA PLASMA FREE METANEPHRINE ANALYSIS KIT, Substantially Equivalent on 2004-01-30. Applicant: Esa, Inc.. Device class: 1.

Clearance details

Applicant: Esa, Inc.
Product code: Code CHQ
Device class: Class 1
Regulation: 21 CFR 862.1165
Advisory panel: Clinical Chemistry
Date received: 2003-07-18
Decision date: 2004-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

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