The following data is part of a premarket notification filed by Zeus Scientific Inc. with the FDA for Zeus Elisa Borrelia Vlse1/pepc10 Igg/igm Test System; Zeus Elisa Borrelia Burgdorferi Igg Test System.
| Device ID | K191398 |
| 510k Number | K191398 |
| Device Name: | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia Burgdorferi IgG Test System |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | ZEUS Scientific Inc. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J. Kopnitsky |
| Correspondent | Mark J. Kopnitsky 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 | 2019-05-24 |
| Decision Date | 2019-07-29 |