The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Hsv Antigen Elisa Kit.
| Device ID | K834449 |
| 510k Number | K834449 |
| Device Name: | HSV ANTIGEN ELISA KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-19 |
| Decision Date | 1984-05-02 |