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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cortisol, Salivary
510(k) Number K102841
Device Name PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
Applicant
Pantex, Div. Bio-Analysis, Inc.
1701 Berkeley St.
Santa Monica,  CA  90404
Applicant Contact ROMULO GARZA
Correspondent
Pantex, Div. Bio-Analysis, Inc.
1701 Berkeley St.
Santa Monica,  CA  90404
Correspondent Contact ROMULO GARZA
Regulation Number862.1205
Classification Product Code
NHG  
Date Received09/29/2010
Decision Date 05/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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