Device Classification Name |
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
|
510(k) Number |
K231481 |
Device Name |
Xpert Xpress CoV-2/Flu/RSV plus |
Applicant |
Cepheid® |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Applicant Contact |
Suzette Chance |
Correspondent |
Cepheid® |
904 Caribbean Drive |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
Yen H. Nguyen |
Regulation Number | 866.3981
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2023 |
Decision Date | 08/17/2023 |
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
|