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CLIA record K790282 and corresponding
510(K) Premarket Notification information

Test System Name ELDONCARDS FOR BLOOD GROUPING ABO AND RH(D)  
Document Number K790282
Analyte Name ABO Group - RBC
Analyte Specialty Immunohematology
Complexity MODERATE
Effective Date 07/27/2001

510(k) Premarket Notification Database

Device Classification Name system, test, automated blood grouping and antibody
510(k) Number K790282
Regulation Number 864.9175
Device Name ELDONCARD
Applicant
NORDISK INFUSER SYSTEM
Classification Product Code
KSZ
Date Received 02/13/1979
Decision Date 05/04/1979
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Statement/Summary/Purged Status Purged, no summary or statement
Type Traditional
Reviewed by Third Party No

Database Updated 7/05/2005

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