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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 K936016
Device Name QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
minneapolis,  MN  55413
Applicant Contact john g yager
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
minneapolis,  MN  55413
Correspondent Contact john g yager
Regulation Number864.7250
Classification Product Code
GGT  
Date Received12/16/1993
Decision Date 07/19/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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