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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
510(k) Number K243070
Device Name Xpert® SA Nasal Complete
Applicant
Cepheid®
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid®
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact Bansari Doshi
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received09/27/2024
Decision Date 10/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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