The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Biomerieux Rsv Direct If Kit.
| Device ID | K912371 |
| 510k Number | K912371 |
| Device Name: | BIOMERIEUX RSV DIRECT IF KIT |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Cheryl Winters-heard |
| Correspondent | Cheryl Winters-heard VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-29 |
| Decision Date | 1991-09-23 |