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FDA 510(k) Application Details - K963424
Device Classification Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
More FDA Info for this Device
510(K) Number
K963424
Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
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Contact
LAURA STORMS-TYLER
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Regulation Number
862.1705
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Classification Product Code
CDT
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More FDA Info for this Product Code
Date Received
08/30/1996
Decision Date
01/14/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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