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FDA 510(k) Application Details - K222638
Device Classification Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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510(K) Number
K222638
Device Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant
Cepheid
904 Caribbean Drive
Sunnyvale, CA 94089 US
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Contact
Suzette Chance
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Regulation Number
866.3740
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Classification Product Code
NJR
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Date Received
09/01/2022
Decision Date
09/27/2023
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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