Company ยท US
BD Diagnostic Systems
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
13recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 4 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 3 |
| GSM | Antisera, Fluorescent, Brucella Spp. | 2 |
| GSN | Antiserum, Positive And Negative Febrile Antigen Control Serum | 2 |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | 2 |
| GSY | Antisera, Fluorescent, All Globulins, Proteus Spp. | 2 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 2 |
| GSK | Antiserum, Francisella Tularensis | 1 |
| MDB | System, Blood Culturing | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 28, 2026 | K260213 | BD BACTEC FXI Culture System BD Diagnostic Systems | MDB |
| Sep 15, 2003 | K032518 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) Bd Diagnostic Systems | JWY |
| Sep 11, 2003 | K032153 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML Bd Diagnostic Systems | LON |
| Aug 19, 2003 | K032259 | PASCO MIC AND MIC/ID PANELS Bd Diagnostic Systems | JWY |
| Jun 6, 2003 | K031429 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML Bd Diagnostic Systems | LON |
| Feb 28, 2003 | K030091 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML Bd Diagnostic Systems | LON |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2004 | BD Diagnostic Systems BD, Febrile Antigen Negative Control Terminated |
GSM | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Brucella Postive Control Antiserum (AMS) Terminated |
GSM | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19) Terminated |
GSY | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Francisella tularensis Antigen Terminated |
GSK | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Proteus OX19 Antigen Terminated |
GSY | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d) Terminated |
GSN | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Salmonella O Group B Antigen (1-4-5-12) Terminated |
GNC | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Salmonella O Group A Antigen (1-2-12) Terminated |
GNC | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Salmonella Flagellar d Antigen (Typhoid H) Terminated |
GNC | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Brucella abortus Antigen Terminated |
GSO | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Salmonella Somatic Polyvalent Antiserum (A,B,D) Terminated |
GSN | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Salmonella O Group D Antigen (9-12) (Typhoid O) Terminated |
GNC | None listed |
| Dec 16, 2004 | BD Diagnostic Systems BD, Brucella melitensis Antigen Terminated |
GSO | None listed |