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FDA 510(k) Application Details - K161495
Device Classification Name
Real Time Nucleic Acid Amplification System
More FDA Info for this Device
510(K) Number
K161495
Device Name
Real Time Nucleic Acid Amplification System
Applicant
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN, TX 78727 US
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Contact
CHRISTIE HUGHES
Other 510(k) Applications for this Contact
Regulation Number
862.2570
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Classification Product Code
OOI
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More FDA Info for this Product Code
Date Received
06/01/2016
Decision Date
06/30/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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