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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Erythropoietin
510(k) Number K894943
Device Name CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
Applicant
Amgen, Inc.
1840 De Havilland
Thousand Oaks,  CA  91320
Applicant Contact SARAH SWANSON
Correspondent
Amgen, Inc.
1840 De Havilland
Thousand Oaks,  CA  91320
Correspondent Contact SARAH SWANSON
Regulation Number864.7250
Classification Product Code
GGT  
Date Received08/03/1989
Decision Date 10/10/1989
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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