The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Cmv-g Test System.
| Device ID | K880679 |
| 510k Number | K880679 |
| Device Name: | BION CMV-G TEST SYSTEM |
| Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
| 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 | GQH |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-19 |
| Decision Date | 1988-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110CMN20100 | K880679 | 000 |
| B110CMM20300 | K880679 | 000 |
| B110CMG20200 | K880679 | 000 |
| B110CMG1200 | K880679 | 000 |
| B110CM20120 | K880679 | 000 |