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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K181751
Device Name HemoCue Hb 801 System
Applicant
HemoCue AB
Kuvettgatan 1
Angelholm,  SE 26271
Applicant Contact Maria Fagerberg
Correspondent
HemoCue AB
Kuvettgatan 1
Angelholm,  SE 26271
Correspondent Contact Maria Fagerberg
Regulation Number864.5620
Classification Product Code
GKR  
Date Received07/02/2018
Decision Date 02/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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