The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Mumps-g Antibody Test System.
| Device ID | K926066 |
| 510k Number | K926066 |
| Device Name: | BION MUMPS-G ANTIBODY TEST SYSTEM |
| Classification | Monitor, Spinal-fluid Pressure, Electrically Powered |
| 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 | CAR |
| CFR Regulation Number | 880.2460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-06-15 |