The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Cmv-g Test System.
Device ID | K880679 |
510k Number | K880679 |
Device Name: | BION CMV-G TEST SYSTEM |
Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
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 | GQH |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-19 |
Decision Date | 1988-06-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B110CMN20100 | K880679 | 000 |
B110CMM20300 | K880679 | 000 |
B110CMG20200 | K880679 | 000 |
B110CMG1200 | K880679 | 000 |
B110CM20120 | K880679 | 000 |