HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY— 510(k) K031348

Name: FDA 510(k) clearance K031348
Creator: U.S. Food and Drug Administration
Published: 2003-06-10

Substantially Equivalent

Salimetrics, LLC

FDA 510(k) clearance K031348 for HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, Substantially Equivalent on 2003-06-10. Applicant: Salimetrics, LLC. Device class: 2.

Clearance details

Applicant: Salimetrics, LLC
Product code: Code NHG
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2003-04-11
Decision date: 2003-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: State College, PA, US

Download summary PDF View on FDA.gov ↗

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