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FDA 510(k) Application Details - K162444
Device Classification Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
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510(K) Number
K162444
Device Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089 US
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Contact
SCOTT A. CAMPBELL
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Regulation Number
866.1640
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Classification Product Code
NQX
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More FDA Info for this Product Code
Date Received
08/31/2016
Decision Date
11/23/2016
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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