The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Direct Identification Control Slide.
| Device ID | K890616 |
| 510k Number | K890616 |
| Device Name: | BION DIRECT IDENTIFICATION CONTROL SLIDE |
| Classification | Quality Control Slides |
| 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 | LJG |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-07 |
| Decision Date | 1989-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110QVZ70020 | K890616 | 000 |
| B110QAD31020 | K890616 | 000 |
| B110QCH41020 | K890616 | 000 |
| B110QCHE45020 | K890616 | 000 |
| B110QCM20020 | K890616 | 000 |
| B110QEP66040 | K890616 | 000 |
| B110QHS35040 | K890616 | 000 |
| B110QME60020 | K890616 | 000 |
| B110QMU80020 | K890616 | 000 |
| B110QP85060 | K890616 | 000 |
| B110QRP63140 | K890616 | 000 |
| B110QRS90020 | K890616 | 000 |
| B110QAB15040 | K890616 | 000 |