The following data is part of a premarket notification filed by Scientific Research with the FDA for Elisa For Herpes Simplex Virus.
| Device ID | K843077 |
| 510k Number | K843077 |
| Device Name: | ELISA FOR HERPES SIMPLEX VIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | SCIENTIFIC RESEARCH 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-06 |
| Decision Date | 1985-06-21 |