The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Arbovirus Igg Ifa Test.
| Device ID | K913617 |
| 510k Number | K913617 |
| Device Name: | ARBOVIRUS IGG IFA TEST |
| Classification | Antisera, Cf, Equine Encephalitis Virus, Eee, Wee |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Carolyn Wagner |
| Correspondent | Carolyn Wagner HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | GQC |
| CFR Regulation Number | 866.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-13 |
| Decision Date | 1992-12-03 |