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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 K171771
Device Name ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Applicant
Siemens Healthcare Diagnostics Inc.
500 GBC Drive
Newark,  DE  19714 -6101
Applicant Contact Alan Haley
Correspondent
Siemens Healthcare Diagnostics Inc.
500 GBC Drive
Newark,  DE  19714 -6101
Correspondent Contact Alan Haley
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received06/14/2017
Decision Date 12/04/2017
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
Recalls CDRH Recalls
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