Company
BD Diagnostic Systems / Lee Laboratories
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | BD Diagnostic Systems / Lee Laboratories DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic. Terminated |
GTQ | 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 | K844407 |
| 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 | K844407 |
| 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 | K844407 |
| 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 | K844407 |