Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
|
510(k) Number |
K101879 |
Device Name |
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 |
Applicant |
CEPHEID |
904 CARIBBEAN DRIVE |
SUNNYVALE,
CA
94089 -1189
|
|
Applicant Contact |
RUSSEL K ENNS, PH.D. |
Correspondent |
CEPHEID |
904 CARIBBEAN DRIVE |
SUNNYVALE,
CA
94089 -1189
|
|
Correspondent Contact |
RUSSEL K ENNS, PH.D. |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 07/06/2010 |
Decision Date | 07/28/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|