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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 K080837
Device Name XPERT MRSA/SA SSTI ASSAY
Applicant
CEPHEID
904 CARIBBEAN DRIVE
sunnyvale,  CA  94089 -1189
Applicant Contact russel k ennis
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
sunnyvale,  CA  94089 -1189
Correspondent Contact russel k ennis
Regulation Number866.1640
Classification Product Code
NQX  
Date Received03/25/2008
Decision Date 09/24/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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