The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Ebv-m (vca) Test System.
| Device ID | K893240 |
| 510k Number | K893240 |
| Device Name: | BION EBV-M (VCA) TEST SYSTEM |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| 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 | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-28 |
| Decision Date | 1989-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110EBN50100 | K893240 | 000 |
| B110EBM50300 | K893240 | 000 |
| B110EBM1200 | K893240 | 000 |
| B110EBG50200 | K893240 | 000 |
| B110EB50120 | K893240 | 000 |