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FDA 510(k) Application Details - K150819
Device Classification Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
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510(K) Number
K150819
Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant
Randox Laboratories Limited
55 Diamond Road
Crumlin BT29 4Qy GB
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Contact
Pauline Armstrong
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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
03/27/2015
Decision Date
08/06/2015
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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