The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Q Fever Igm Ifa Test.
| Device ID | K922374 |
| 510k Number | K922374 |
| Device Name: | Q FEVER IGM IFA TEST |
| Classification | Antiserum, Fluorescent, Q Fever |
| 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 | GPJ |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1992-10-21 |