Device Classification Name |
Herpes Simplex Virus Nucleic Acid Amplification Assay
|
510(k) Number |
K162673 |
Device Name |
Aptima Herpes Simplex Viruses 1 & 2 Assay |
Applicant |
HOLOGIC, INC. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
Ron Domingo |
Correspondent |
HOLOGIC, INC. |
10210 GENETIC CENTER DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
Ron Domingo |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 09/26/2016 |
Decision Date | 06/15/2017 |
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
|
|
|