The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Varicella Zoster Virus.
| Device ID | K894622 |
| 510k Number | K894622 |
| Device Name: | VARICELLA ZOSTER VIRUS |
| Classification | Antigen, Cf, (including Cf Control), Varicella-zoster |
| Applicant | BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Contact | Judy Mccormack |
| Correspondent | Judy Mccormack BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Product Code | GQW |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110VZN70100 | K894622 | 000 |
| B110VZM70300 | K894622 | 000 |
| B110VZG70200 | K894622 | 000 |
| B110VZ70120 | K894622 | 000 |