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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated urinalysis system
510(k) Number K053253
Device Name HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
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 Number862.2900
Classification Product Code
KQO  
Subsequent Product Code
JIQ  
Date Received11/21/2005
Decision Date 02/17/2006
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
Recalls CDRH Recalls
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