Bd Biosciences
Medical device manufacturer in San Jose, CA.
10510(k) clearances
0PMA approvals
4recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…OYE · Traditional | 02/27/2015SE |
| K090967 | BD Multitest 6-COLOR TBNK Reagent, Model 644611GKZ · Traditional | 07/31/2009SE |
| K081213 | BD Facscount CD4 Reagents with Model 339010GKZ · Traditional | 08/14/2008SE |
| K071143 | BD Tritest CD3/CD4/CD45, Model 340383GKZ · Special | 06/06/2007SE |
| K071141 | BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402GKZ · Special | 06/06/2007SE |
| K062087 | BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962GKZ · Special | 09/14/2006SE |
| K060375 | BD Multitest 6-COLOR TBNK Reagent with BD Trucount Tubes with Models 337 and 166GKZ · Traditional | 06/06/2006SE |
| K041074 | BD Facscanto with BD Facsanto SoftwareGKZ · Traditional | 09/17/2004SE |
| K000611 | Steller CD61 Assay for Use on the Imagn 2000 Microvolume FluorimeterGKZ · Traditional | 05/18/2000SE |
| K000897 | Calibrite PERCP-CY5.5 Beads and Facscomp SoftwareGKZ · Traditional | 05/05/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1530-2008 | BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog…Values might not update in statistics views after certain functions are performed in a worksheet. | 12/21/2007Terminated |
| Z-0526-2008 | BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and…Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit… | 10/02/2007Terminated |
| Z-0570-2008 | BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X…Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the… | 09/06/2007Terminated |
| Z-1525-2008 | FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis…When data file containing one or no fluoresence parameters is exported, the software will automatically… | 04/05/2007Terminated |