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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 K182651
FOIA Releasable 510(k) K182651
Device Name HbA1c Advanced
Applicant
Beckman Coulter Ireland, Inc.
Lismeehan
O'Callaghan'S Mills,  IE V94 PP63
Applicant Contact Catriona Hourigan
Correspondent
Beckman Coulter Ireland, Inc.
Lismeehan
O'Callaghan'S Mills,  IE V94 PP63
Correspondent Contact Catriona Hourigan
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received09/24/2018
Decision Date 01/16/2019
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
Predetermined Change
Control Plan Authorized		 No
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