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FDA 510(k) Application Details - K162772
Device Classification Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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510(K) Number
K162772
Device Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
AUSTIN, TX 78727 US
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Contact
CHRISTIE HUGHES
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Regulation Number
866.3740
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Classification Product Code
NJR
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Date Received
10/03/2016
Decision Date
12/23/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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