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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A1c Test System
510(k) Number K200256
Device Name ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact Julie Warren
Correspondent
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact Julie Warren
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received02/03/2020
Decision Date 07/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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