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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 K061047
Device Name HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
Applicant
HEMOCUE AB
40 EMPIRE DRIVE
LAKE FOREST,  CA  92630
Applicant Contact ALLAN WHITE
Correspondent
HEMOCUE AB
40 EMPIRE DRIVE
LAKE FOREST,  CA  92630
Correspondent Contact ALLAN WHITE
Regulation Number864.5620
Classification Product Code
GKR  
Date Received04/14/2006
Decision Date 06/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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