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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
Device Name LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
Applicant
Luminex Corp.
12212 Technology Blvd.
Austin,  TX  78727
Applicant Contact Oliver Meek
Correspondent
Luminex Corp.
12212 Technology Blvd.
Austin,  TX  78727
Correspondent Contact Oliver Meek
Regulation Number862.2570
Classification Product Code
NSU  
Date Received05/09/2012
Decision Date 01/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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