The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Borrelia Burgdorferi Antigen Substrate Slide.
| Device ID | K901054 |
| 510k Number | K901054 |
| Device Name: | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Contact | Edward Nowakowski |
| Correspondent | Edward Nowakowski BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110BBN61100 | K901054 | 000 |
| B110BBM61300 | K901054 | 000 |
| B110BBG61200 | K901054 | 000 |