The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Lyme Disease Ifa (igm).
| Device ID | K883767 |
| 510k Number | K883767 |
| Device Name: | LYME DISEASE IFA (IGM) |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | B Wagner |
| Correspondent | B Wagner 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 | 1988-09-06 |
| Decision Date | 1989-03-15 |