The following data is part of a premarket notification filed by Monoclonal Antibodies, Inc. with the FDA for Ramp Herpes Simplex Virus (hsv) (cct).
| Device ID | K874863 |
| 510k Number | K874863 |
| Device Name: | RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | MONOCLONAL ANTIBODIES, INC. 995 BENICIA Sunnyvale, CA 94086 |
| Contact | Griffin Fitzgerald |
| Correspondent | Griffin Fitzgerald MONOCLONAL ANTIBODIES, INC. 995 BENICIA Sunnyvale, CA 94086 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-25 |
| Decision Date | 1988-02-16 |