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FDA 510(k) Application Details - K133067
Device Classification Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
More FDA Info for this Device
510(K) Number
K133067
Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVE
TARRYTOWN, NY 10591 US
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Contact
KIRA GORDON
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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
09/27/2013
Decision Date
11/22/2013
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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