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FDA 510(k) Application Details - K000239
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K000239
Device Name
Assay, Glycosylated Hemoglobin
Applicant
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE, MA 02142-1562 US
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Contact
BARBARA PIZZA
Other 510(k) Applications for this Contact
Regulation Number
864.7470
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Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
01/27/2000
Decision Date
03/21/2000
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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