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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
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