Device Classification Name |
nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
|
510(k) Number |
K200866 |
Device Name |
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) |
Applicant |
Hologic, Inc. |
10210 Genetic Center Drive |
san diego,
CA
92121
|
|
Applicant Contact |
anila tarte |
Correspondent |
Hologic, Inc. |
10210 Genetic Center Drive |
san diego,
CA
92121
|
|
Correspondent Contact |
anila tarte |
Regulation Number | 866.3393
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/01/2020 |
Decision Date | 05/17/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
summary |
summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|