FDA 510(k) Applications for Medical Device Product Code: NHG (Enzyme Immunoassay, Cortisol, Salivary)

FDA 510(k) Applications for Medical Device Product Code "NHG"
(Enzyme Immunoassay, Cortisol, Salivary)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K051733	DRG INTL., INC.	ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL	12/07/2005
K150528	IBL INTERNATIONAL GMBH	Cortisol Saliva Luminescence Immunoassay	11/25/2015
K102841	PANTEX, DIV. BIO-ANALYSIS, INC.	PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY	05/08/2012
K070788	Roche Diagnostics	ELECSYS CORTISOL TEST SYSTEM	10/05/2007
K043175	ROCHE DIAGNOSTICS CORP.	ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE	11/24/2004
K031348	SALIMETRICS LLC.	HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY	06/10/2003
K011323	SALIMETRICS LLC.	HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102	12/17/2001