ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL— 510(k) K051733

Name: FDA 510(k) clearance K051733
Creator: U.S. Food and Drug Administration
Published: 2005-12-07

Substantially Equivalent

Drg Intl., Inc.

FDA 510(k) clearance K051733 for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL, Substantially Equivalent on 2005-12-07. Applicant: Drg Intl., Inc.. Device class: 2.

Clearance details

Applicant: Drg Intl., Inc.
Product code: Code NHG
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2005-06-28
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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