K896097 is an FDA 510(k) clearance for the VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY. This device is classified as a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I - General Controls, product code GQG).
Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 26, 1990, 129 days after receiving the submission on October 20, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K896097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1989 |
| Decision Date | February 26, 1990 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |