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FDA 510(k) Application Details - K992766
Device Classification Name
System, Test, Low Density, Lipoprotein
More FDA Info for this Device
510(K) Number
K992766
Device Name
System, Test, Low Density, Lipoprotein
Applicant
GENZYME CORP.
500 KENDALL STREET
CAMBRIDGE, MA 02142-1562 US
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Contact
BARBARA PIZZA
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Regulation Number
862.1475
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Classification Product Code
MRR
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More FDA Info for this Product Code
Date Received
08/17/1999
Decision Date
10/18/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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