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FDA 510(k) Application Details - K191160
Device Classification Name
More FDA Info for this Device
510(K) Number
K191160
Device Name
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Avenue
Toronto M5g 1y8 CA
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Contact
Tina Ip
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PCH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2019
Decision Date
11/04/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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