The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Mumps Virus.
| Device ID | K894624 |
| 510k Number | K894624 |
| Device Name: | MUMPS VIRUS |
| Classification | Antiserum, Fluorescent, Mumps Virus |
| 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 | GRA |
| CFR Regulation Number | 866.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110MUN80100 | K894624 | 000 |
| B110MUM80300 | K894624 | 000 |
| B110MUG80200 | K894624 | 000 |
| B110MUG600 | K894624 | 000 |
| B110MUG1200 | K894624 | 000 |
| B110MU80120 | K894624 | 000 |
| B110MU80060 | K894624 | 000 |