The following data is part of a premarket notification filed by Theranos, Inc. with the FDA for Theranos Herpes Simplex Virus-1 Igg Assay.
| Device ID | K143236 |
| 510k Number | K143236 |
| Device Name: | Theranos Herpes Simplex Virus-1 IgG Assay |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | THERANOS, INC. 1701 PAGE MILL ROAD Palo Alto, CA 94304 |
| Contact | Brad Arington |
| Correspondent | Brad Arington THERANOS, INC. 1701 PAGE MILL ROAD Palo Alto, CA 94304 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-12 |
| Decision Date | 2015-07-02 |
| Summary: | summary |