The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Ebv-g (vca) Test System.
| Device ID | K891785 |
| 510k Number | K891785 |
| Device Name: | BION EBV-G (VCA) TEST SYSTEM |
| Classification | Antiserum, Fluorescent, Epstein-barr Virus |
| Applicant | BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Contact | Edward Norwakowski |
| Correspondent | Edward Norwakowski BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Product Code | JRY |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110EBG1200 | K891785 | 000 |