510(k) K081825 ยท LSL Dna-Reagents, Neisseria
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Dec 11, 2008 |
| Received | Jun 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2013 | Becton Dickinson & Co. BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Rea Terminated |
JTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.