Device Classification Name |
nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
|
510(k) Number |
K200436 |
Device Name |
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit |
Applicant |
Hologic, Inc. |
10210 Genetic Center Drive |
San Diego,
CA
92121
|
|
Applicant Contact |
Jill Wyland |
Correspondent |
Hologic, Inc. |
10210 Genetic Center Drive |
San Diego,
CA
92121
|
|
Correspondent Contact |
Jill Wyland |
Regulation Number | 866.3393
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/24/2020 |
Decision Date | 03/23/2020 |
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
|
|
|