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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated Blood Grouping And Antibody
510(k) Number K790282
Device Name ELDONCARD
Applicant
Nordisk Infuser System
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Nordisk Infuser System
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received02/13/1979
Decision Date 05/04/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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