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FDA 510(k) Application Details - K133302
Device Classification Name
Instrumentation For Clinical Multiplex Test Systems
More FDA Info for this Device
510(K) Number
K133302
Device Name
Instrumentation For Clinical Multiplex Test Systems
Applicant
LUMINEX CORP.
12212 TECHNOLOGY BLVD.
AUSTIN, TX 78727-6115 US
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Contact
CHRISTIE HUGHES
Other 510(k) Applications for this Contact
Regulation Number
862.2570
More FDA Info for this Regulation Number
Classification Product Code
NSU
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More FDA Info for this Product Code
Date Received
10/25/2013
Decision Date
01/10/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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