510(k) K140447 ยท OOI Real Time Nucleic Acid Amplification System
BD VIPER LT SYSTEM
| Applicant | Becton, Dickinson and Company, Sparks MD, US |
| Decision | Substantially Equivalent, May 20, 2014 |
| Received | Feb 21, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2017 | Bd Diagnostic BD Viper LT software, version 3.00H Terminated |
OOI | None listed |
| Jun 18, 2015 | Becton Dickinson & Co. BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. Terminated |
OOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.