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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 K882686
Device Name ERYTHROPOIETIN ENZYME IMMUNOASSAY
Applicant
Amgen, Inc.
1840 De Havilland
Thousand Oaks,  CA  91320
Applicant Contact SARAH C SWANSON
Correspondent
Amgen, Inc.
1840 De Havilland
Thousand Oaks,  CA  91320
Correspondent Contact SARAH C SWANSON
Regulation Number864.7250
Classification Product Code
GGT  
Date Received06/30/1988
Decision Date 12/20/1988
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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