Device Classification Name |
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
|
510(k) Number |
K060540 |
Device Name |
XPERT, GENEXPERT DX SYSTEM |
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 | 866.3740
|
Classification Product Code |
|
Date Received | 03/01/2006 |
Decision Date | 07/25/2006 |
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
|
|
|