The following data is part of a premarket notification filed by Diagnon Corp. with the FDA for Diagnon Herpes Immunoperoxidase Typing Test.
| Device ID | K851635 |
| 510k Number | K851635 |
| Device Name: | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
| Contact | William C Gordon |
| Correspondent | William C Gordon DIAGNON CORP. PHAIR OFFICE PARK 1050 WEST ST. Laurel, MD 20707 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-18 |
| Decision Date | 1985-10-10 |