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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cortisol
510(k) Number K202826
Device Name IMMULITE® 2000 Cortisol
Applicant
Siemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy, Llanberis
Caerarfon,  GB LL55 4EL
Applicant Contact Malgorzata Robak
Correspondent
Siemens Healthcare Diagnostics Products, Ltd.
Glyn Rhonwy, Llanberis
Caerarfon,  GB LL55 4EL
Correspondent Contact Malgorzata Robak
Regulation Number862.1205
Classification Product Code
CGR  
Date Received09/24/2020
Decision Date 01/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
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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