The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Lyme Disease Ifa (igg).
| Device ID | K883487 |
| 510k Number | K883487 |
| Device Name: | LYME DISEASE IFA (IGG) |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Lee Fuller |
| Correspondent | Lee Fuller HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-12-13 |