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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrumentation for clinical multiplex test systems
510(k) Number K121399
Model F3DIVD-CAL-K25, F3DIVD-PVER-K25, 40-5000
Device Name LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
Original Applicant
LUMINEX CORP.
12212 technology blvd
austin,  TX  78727
Original Contact oliver meek
Regulation Number862.2570
Classification Product Code
NSU  
Date Received05/09/2012
Decision Date 01/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Immunology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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