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FDA 510(k) Application Details - DEN050003
Device Classification Name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
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510(K) Number
DEN050003
Device Name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Applicant
PREANALYTIX GMBH
1 BECTON DRIVE
MC 300
FRANKLIN LAKES, NJ 07417 US
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JING ZHANG
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Regulation Number
866.4070
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Classification Product Code
NTW
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Date Received
02/28/2005
Decision Date
04/18/2005
Decision
DENG -
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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