The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ifa Test For Antibodies To Borrelia Burgdorferi.
| Device ID | K871246 |
| 510k Number | K871246 |
| Device Name: | IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Donald Tourville,phd |
| Correspondent | Donald Tourville,phd ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1987-08-25 |