The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Hybriwick System: Herpes Dna Probe Test Kit.
| Device ID | K873529 |
| 510k Number | K873529 |
| Device Name: | HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens, OH 45701 |
| Contact | Scholl, Phd |
| Correspondent | Scholl, Phd DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens, OH 45701 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-01 |
| Decision Date | 1988-08-25 |