Panels › Microbiology › Product code GTJ · Class 2
Antisera, All Groups, N. Meningitidis
Regulation 866.3390
0510(k)s in 12 months (16 all time)
1recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in GTJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Wellcome Diagnostics | 5 | 0 |
| BD Diagnostic Systems / Lee Laboratories | 0 | 4 |
| Armkel, LLC | 3 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 0 |
| Pharmacia, Inc. | 2 | 0 |
| Burroughs Wellcome Co. | 1 | 0 |
| Microscan Div. Baxter Healthcare Corp. | 1 | 0 |
| Remel Europe Ltd. | 0 | 1 |
| Vitek Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Remel Europe Ltd. Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics Open, Classified |
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 | 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 |
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