Device Classification Name |
nucleic acid amplification assay system, group b streptococcus, direct specimen test
|
510(k) Number |
K203429 |
Device Name |
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System |
Applicant |
Cepheid |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Applicant Contact |
Yi-Ping Lin |
Correspondent |
Cepheid |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
Robert Resnick |
Regulation Number | 866.3740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/20/2020 |
Decision Date | 05/09/2022 |
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
|
|
|