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FDA 510(k) Application Details - DEN160028
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN160028
Device Name
ipsogen JAK2 RGQ PCR Kit
Applicant
QIAGEN INC
19300 GERMANTOWN ROAD
GERMANTOWN, MD 20874 US
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Contact
LINDSEY HOWARD
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Regulation Number
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Classification Product Code
PSU
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Date Received
07/01/2016
Decision Date
03/27/2017
Decision
DENG -
Classification Advisory Committee
MG -
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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