Device Classification Name |
Trichomonas Vaginalis Nucleic Acid Amplification Test System
|
510(k) Number |
K161619 |
Device Name |
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems |
Applicant |
Cepheid |
904 Carribean Drive |
Sunnyvale,
CA
94089 -1189
|
|
Applicant Contact |
Scott A. Campbell |
Correspondent |
Cepheid |
904 Carribean Drive |
Sunnyvale,
CA
94089 -1189
|
|
Correspondent Contact |
Scott A. Campbell |
Regulation Number | 866.3860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/13/2016 |
Decision Date | 08/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|