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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Antigen, Antiserum, Control
510(k) Number K884075
Device Name IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN
Applicant
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Applicant Contact TIMO RAINES
Correspondent
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Correspondent Contact TIMO RAINES
Regulation Number866.5880
Classification Product Code
DDG  
Date Received09/27/1988
Decision Date 10/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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