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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 K203270
Device Name IMMULITE/IMMULITE® 1000 Cortisol
Applicant
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis,  GB LL55 4EL
Applicant Contact Malgorzata Robak
Correspondent
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy, Llanberis
Caernarfon,  GB LL55 4EL
Correspondent Contact Malgorzata Robak
Regulation Number862.1205
Classification Product Code
CGR  
Date Received11/05/2020
Decision Date 01/15/2021
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
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