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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 K931756
Device Name QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
Applicant
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Applicant Contact KARYN STEERE
Correspondent
R&D Systems, Inc.
614 Mckinley Pl NE
Minneapolis,  MN  55413
Correspondent Contact KARYN STEERE
Regulation Number864.7250
Classification Product Code
GGT  
Date Received04/08/1993
Decision Date 04/21/1994
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
Recalls CDRH Recalls
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