The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Rickettsial Igg And Igm Ifa Kit.
| Device ID | K864110 |
| 510k Number | K864110 |
| Device Name: | RICKETTSIAL IGG AND IGM IFA KIT |
| Classification | Antiserum, Typhus Fever |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Steven A Evans |
| Correspondent | Steven A Evans HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | GPN |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1987-03-12 |