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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 K150528
Device Name Cortisol Saliva Luminescence Immunoassay
Applicant
Ibl International GmbH
Flughafenstrasse 52 A
Hamburg,  DE D-22335
Applicant Contact NICOLA KAISER
Correspondent
Ibl International GmbH
Flughafenstrasse 52 A
Hamburg,  DE D-22335
Correspondent Contact NICOLA KAISER
Regulation Number862.1205
Classification Product Code
NHG  
Date Received03/02/2015
Decision Date 11/25/2015
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
Recalls CDRH Recalls
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