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Device Classification Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
510(k) Number
K070462
Device Name
XPERT MRSA
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089 -1189
Applicant Contact
RUSSEL K ENNS
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089 -1189
Correspondent Contact
RUSSEL K ENNS
Regulation Number
866.1640
Classification Product Code
NQX
Date Received
02/16/2007
Decision Date
04/17/2007
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
Recalls
CDRH Recalls
-
-