The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Respiratory Syncytial Virus.
Device ID | K894623 |
510k Number | K894623 |
Device Name: | RESPIRATORY SYNCYTIAL VIRUS |
Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
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 | LKT |
CFR Regulation Number | 866.3480 [🔎] |
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 |
---|---|---|
B110RSN90100 | K894623 | 000 |
B110RSG90200 | K894623 | 000 |
B110RS90120 | K894623 | 000 |