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FDA 510(k) Application Details - K112125
Device Classification Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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510(K) Number
K112125
Device Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI, OH 45244 US
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Contact
SUSAN D ROLIH
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Regulation Number
866.3740
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Classification Product Code
NJR
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More FDA Info for this Product Code
Date Received
07/25/2011
Decision Date
12/05/2011
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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