PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY— 510(k) K102841

Name: FDA 510(k) clearance K102841
Creator: U.S. Food and Drug Administration
Published: 2012-05-08

Substantially Equivalent

Pantex, Div. Bio-Analysis, Inc.

FDA 510(k) clearance K102841 for PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY, Substantially Equivalent on 2012-05-08. Applicant: Pantex, Div. Bio-Analysis, Inc.. Device class: 2.

Clearance details

Applicant: Pantex, Div. Bio-Analysis, Inc.
Product code: Code NHG
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2010-09-29
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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