The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Hillcrest Amebiasis Iha Test.
| Device ID | K853448 |
| 510k Number | K853448 |
| Device Name: | HILLCREST AMEBIASIS IHA TEST |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Fuller |
| Correspondent | Fuller HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1985-08-28 |