| Device Classification Name |
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
|
|---|
| 510(k) Number |
K143236 |
|---|
| Device Name |
Theranos Herpes Simplex Virus-1 IgG Assay |
|---|
| Applicant |
| THERANOS, INC. |
| 1701 PAGE MILL ROAD |
|
PALO ALTO,
CA
94304
|
|
| Applicant Contact |
Brad Arington |
| Correspondent |
| THERANOS, INC. |
| 1701 PAGE MILL ROAD |
|
PALO ALTO,
CA
94304
|
|
| Correspondent Contact |
Brad Arington |
| Regulation Number | 866.3305
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/12/2014 |
|---|
| Decision Date | 07/02/2015 |
|---|
| 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
|
|---|