The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Herpes Simplex Virus Type 1 Igg Elisa Test.
| Device ID | K131334 |
| 510k Number | K131334 |
| Device Name: | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD ST Davis, CA 95618 |
| Contact | Napleon Monce |
| Correspondent | Napleon Monce GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD ST Davis, CA 95618 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-09 |
| Decision Date | 2014-02-28 |
| Summary: | summary |