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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 K932650
Device Name ERYTHROPOIETIN IMMUNOASSAY KIT
Applicant
Nichols Institute
33608 Ortega Highway
San Juan Capistrano,  CA  92690
Applicant Contact DAVE D SMITH
Correspondent
Nichols Institute
33608 Ortega Highway
San Juan Capistrano,  CA  92690
Correspondent Contact DAVE D SMITH
Regulation Number864.7250
Classification Product Code
GGT  
Date Received06/02/1993
Decision Date 03/11/1994
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
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