The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Borrelia Burgdorferi Igm Western Blot Test System.
| Device ID | K991185 |
| 510k Number | K991185 |
| Device Name: | BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark Kopnitsky |
| Correspondent | Mark Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-08 |
| Decision Date | 1999-09-03 |