The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vidas Respiratory Syncytial Virus (rsv) Assay.
| Device ID | K896097 |
| 510k Number | K896097 |
| Device Name: | VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Carol K Gravens |
| Correspondent | Carol K Gravens VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1990-02-26 |