The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Bion Ebv-m (vca) Test System.
Device ID | K893240 |
510k Number | K893240 |
Device Name: | BION EBV-M (VCA) TEST SYSTEM |
Classification | Antibody Igm, If, Epstein-barr Virus |
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 | LJN |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-28 |
Decision Date | 1989-07-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B110EBN50100 | K893240 | 000 |
B110EBM50300 | K893240 | 000 |
B110EBM1200 | K893240 | 000 |
B110EBG50200 | K893240 | 000 |
B110EB50120 | K893240 | 000 |