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FDA 510(k) Application Details - K971162
Device Classification Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
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510(K) Number
K971162
Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant
GENZYME CORP.
101 BINNEY ST. ONE KENDALL
SQUARE
CAMBRIDGE, MA 02139-1562 US
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Contact
Nancy E Isaac
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Regulation Number
862.1475
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Classification Product Code
LBS
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More FDA Info for this Product Code
Date Received
03/31/1997
Decision Date
06/16/1997
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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