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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 K926390
Device Name PREDICTA ERYTHROPOIETIN KIT
Applicant
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Applicant Contact ALODIA M RUIZ
Correspondent
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Correspondent Contact ALODIA M RUIZ
Regulation Number864.7250
Classification Product Code
GGT  
Date Received12/22/1992
Decision Date 06/25/1993
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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