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FDA 510(k) Application Details - DEN040002
Device Classification Name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
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510(K) Number
DEN040002
Device Name
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Applicant
PERKINELMER LIFE SCIENCES, INC.
3985 EASTERN ROAD
NORTON, OH 44203 US
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CINDY LLOYD
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Regulation Number
862.1055
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Classification Product Code
NQL
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Date Received
07/02/2004
Decision Date
08/24/2004
Decision
DENG -
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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