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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 K133302
Device Name FLEXMAP 3D
Applicant
Luminex Corp.
12212 Technology Blvd.
Austin,  TX  78727
Applicant Contact CHRISTIE HUGHES
Correspondent
Luminex Corp.
12212 Technology Blvd.
Austin,  TX  78727
Correspondent Contact CHRISTIE HUGHES
Regulation Number862.2570
Classification Product Code
NSU  
Date Received10/25/2013
Decision Date 01/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Pathology
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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