Device Classification Name |
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
|
510(k) Number |
K121539 |
Device Name |
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) |
Applicant |
CEPHEID |
904 CARIBBEAN DRIVE |
SUNNYVALE,
CA
94089 -1189
|
|
Applicant Contact |
KERRY J FLOM |
Correspondent |
CEPHEID |
904 CARIBBEAN DRIVE |
SUNNYVALE,
CA
94089 -1189
|
|
Correspondent Contact |
KERRY J FLOM |
Regulation Number | 866.3740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/24/2012 |
Decision Date | 11/02/2012 |
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
|
|
|