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FDA 510(k) Application Details - K954898
Device Classification Name
Assay, Erythropoietin
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510(K) Number
K954898
Device Name
Assay, Erythropoietin
Applicant
GENZYME CORP.
ONE KENDALL SQUARE
CAMBRIDGE, MA 02139 US
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Contact
ALODIA M RUIZ
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Regulation Number
864.7250
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Classification Product Code
GGT
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More FDA Info for this Product Code
Date Received
09/20/1995
Decision Date
02/05/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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