The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Herpes-iha Kit.
| Device ID | K822095 |
| 510k Number | K822095 |
| Device Name: | HERPES-IHA KIT |
| Classification | Chair, Dental, With Operative Unit |
| Applicant | HILLCREST BIOLOGICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLC |
| CFR Regulation Number | 872.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-16 |
| Decision Date | 1983-04-05 |