The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Hsv1-g Or Hsv2-g Test System.
| Device ID | K881261 |
| 510k Number | K881261 |
| Device Name: | BION HSV1-G OR HSV2-G TEST SYSTEM |
| Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
| 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 | GQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-24 |
| Decision Date | 1988-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110HSN35100 | K881261 | 000 |
| B110HSM35300 | K881261 | 000 |
| B110HSG35200 | K881261 | 000 |
| B110HS2G1200 | K881261 | 000 |
| B110HS240120 | K881261 | 000 |
| B110HS1G1200 | K881261 | 000 |
| B110HS130120 | K881261 | 000 |