Company ยท US
Bd Biosciences
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (1 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2026 | K260215 | BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) Bd Biosciences | OYE |
| Feb 27, 2015 | K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) Bd Biosciences | OYE |
| Jul 31, 2009 | K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 Bd Biosciences | GKZ |
| Aug 14, 2008 | K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 Bd Biosciences | GKZ |
| Jun 6, 2007 | K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 Bd Biosciences | GKZ |
| Jun 6, 2007 | K071141 | BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 Bd Biosciences | GKZ |
| Sep 14, 2006 | K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 Bd Biosciences | GKZ |
| Jun 6, 2006 | K060375 | BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 Bd Biosciences | GKZ |
| Sep 17, 2004 | K041074 | BD FACSCANTO WITH BD FACSANTO SOFTWARE Bd Biosciences | GKZ |
| May 18, 2000 | K000611 | STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER Bd Biosciences | GKZ |
| May 5, 2000 | K000897 | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE Bd Biosciences | GKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2008 | BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609
Flexible data acquistion and analysis package specifically designed for digital-based Terminated |
GKZ | K062087 |
| Aug 8, 2008 | BD Biosciences BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System
Model/Catalog number 642685
Software is used to simplify acquisition of flow cytometry data. Terminated |
GKZ | K040725 K062087 |
| Apr 10, 2008 | BD Biosciences BD FACS Sample Prep Assistant II, Part Number: 337170;
Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131 Terminated |
GKI | K050191 |
| Mar 4, 2008 | BD Biosciences BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131. Terminated |
GKZ | K963963 |