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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 K073506
Device Name LUMINEX LX 100/200 INSTRUMENT
Applicant
Luminex Corp.
439 University Ave. Suite
2000
Toronto,  CA M5G 1Y8
Applicant Contact NANCY KRUNIC
Correspondent
Luminex Corp.
439 University Ave. Suite
2000
Toronto,  CA M5G 1Y8
Correspondent Contact NANCY KRUNIC
Regulation Number862.2570
Classification Product Code
NSU  
Date Received12/13/2007
Decision Date 03/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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