510(k) K022133 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
BD DIRECTIGEN EZ RSV KIT
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Dec 10, 2002 |
| Received | Jul 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Becton Dickinson & Co. Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030. Terminated |
GQG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.