The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Epstein-barr Virus-nuclear Antigen.
Device ID | K894626 |
510k Number | K894626 |
Device Name: | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN |
Classification | Test, Antigen, Nuclear, Epstein-barr 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 | LLM |
CFR Regulation Number | 866.3235 [🔎] |
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 |
---|---|---|
B110NA51400 | K894626 | 000 |
B110NA51120 | K894626 | 000 |