The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Immunodiagnostic Assay System Herpes Simplex Virus.
| Device ID | K910499 |
| 510k Number | K910499 |
| Device Name: | IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | VITEK SYSTEMS, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Winters Heard |
| Correspondent | Winters Heard VITEK SYSTEMS, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-05-01 |