The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Leptospirosis Iha.
| Device ID | K880417 |
| 510k Number | K880417 |
| Device Name: | LEPTOSPIROSIS IHA |
| Classification | Antigens, All, Leptospira Spp. |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Moore, Phd |
| Correspondent | Moore, Phd HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | GRY |
| CFR Regulation Number | 866.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-01 |
| Decision Date | 1988-04-12 |