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510(k) K011323

Device
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
Applicant
SALIMETRICS LLC.
510(k) number
K011323
Product code
NHG  
Decision
Substantially Equivalent (SESE)
Decision date
2001-12-17
Date received
2001-05-01
Regulation
862.1205
Classification name
Enzyme Immunoassay, Cortisol, Salivary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EVE SCHWARTZ
Address
101 Innovation Blvd., Suite 302 State College PA US 16803 16803

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150528Cortisol Saliva Luminescence ImmunoassayIbl International GmbH2015-11-25
K102841PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYPantex, Div. Bio-Analysis, Inc.2012-05-08
K070788ELECSYS CORTISOL TEST SYSTEMRoche Diagnostics2007-10-05
K051733ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOLDrg Intl., Inc.2005-12-07
K043175ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPERoche Diagnostics Corp.2004-11-24
K031348HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAYSalimetrics, LLC2003-06-10

Legacy Summary#

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FDA Review#

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