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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K170623
Device Name ACE Hemoglobin A1c (HbA1c) Reagent
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
4 Henderson Drive
West Caldwell,  NJ  07006
Applicant Contact Barbara Phillips
Correspondent
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
4 Henderson Drive
West Caldwell,  NJ  07006
Correspondent Contact Barbara Phillips
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/01/2017
Decision Date 02/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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