510(k) K180438 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
| Applicant | Bd, San Diego CA, US |
| Decision | Substantially Equivalent, Mar 20, 2018 |
| Received | Feb 20, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2022 | Becton Dickinson & Co. BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings.
Catalog Number: 256066 Open, Classified |
PSZ | None listed |
| Apr 3, 2019 | Becton Dickinson & Co. BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices.
Catalog Number: 256066 Terminated |
PSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.