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FDA 510(k) Application Details - K172402
Device Classification Name
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510(K) Number
K172402
Device Name
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Applicant
Luminex Corporation
12212 Technology Blvd.
Austin, TX 78727 US
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Contact
Jennifer Grimes
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Regulation Number
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Classification Product Code
PGX
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Date Received
08/09/2017
Decision Date
10/30/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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