The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Hsv Antigen Elisa Test.
| Device ID | K915551 |
| 510k Number | K915551 |
| Device Name: | ORTHO HSV ANTIGEN ELISA TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Kim W Gray |
| Correspondent | Kim W Gray ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. 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 | 1991-12-11 |
| Decision Date | 1992-04-22 |