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 |