The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Herpes.
| Device ID | K811021 |
| 510k Number | K811021 |
| Device Name: | HERPES |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | IMMUNO-DIAGNOSTIC PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-15 |
| Decision Date | 1981-11-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HERPES 73420400 not registered Dead/Abandoned |
PRITCHARD, DAVID LIO E AND MR. 1983-04-06 |