510(k) K844407 ยท GTJ Antisera, All Groups, N. Meningitidis
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Jan 25, 1985 |
| Received | Nov 13, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2008 | BD Diagnostic Systems / Lee Laboratories BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dickinson and Company, Sparks, MD 21152. Th Terminated |
GTJ | None listed |
| Aug 8, 2008 | BD Diagnostic Systems / Lee Laboratories BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The Terminated |
GTJ | None listed |
| Aug 8, 2008 | BD Diagnostic Systems / Lee Laboratories BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The Terminated |
GTJ | None listed |
| Aug 8, 2008 | BD Diagnostic Systems / Lee Laboratories BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. Th Terminated |
GTJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.