Company ยท US
Becton Dickinson Immunocytometry Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2004. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 21 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2004 | K040725 | BD FACSCANTO SYSTEM Becton Dickinson Immunocytometry Systems | GKZ |
| Sep 10, 2004 | K040026 | BD FACS 7-COLOR SETUP BEADS Becton Dickinson Immunocytometry Systems | GKZ |
| May 22, 1998 | K980858 | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION Becton Dickinson Immunocytometry Systems | GKZ |
| Mar 11, 1998 | K974360 | MULTITEST CD3/CD8/CD45/CD4 Becton Dickinson Immunocytometry Systems | GKZ |
| Feb 17, 1998 | K973483 | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET Becton Dickinson Immunocytometry Systems | GKZ |
| Dec 1, 1997 | K971205 | TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems | GKZ |
| Nov 25, 1997 | K971110 | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems | GKZ |
| Nov 21, 1997 | K970326 | TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems | GKZ |
| Nov 21, 1997 | K965053 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems | GKZ |
| Oct 22, 1997 | K970742 | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems | GKZ |
| Aug 26, 1997 | K970836 | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS Becton Dickinson Immunocytometry Systems | GKZ |
| Dec 12, 1996 | K963963 | MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS Becton Dickinson Immunocytometry Systems | GKZ |
| Feb 20, 1996 | K950342 | TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems | GKZ |
| Feb 20, 1996 | K946055 | TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems | GKZ |
| Nov 20, 1995 | K953302 | FACS LOADER SYSTEM Becton Dickinson Immunocytometry Systems | GKZ |
| Aug 22, 1995 | K950057 | TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems | GKZ |
| Sep 30, 1994 | K925274 | AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS Becton Dickinson Immunocytometry Systems | GKZ |
| Sep 9, 1994 | K933486 | FASCOUNT SYSTME Becton Dickinson Immunocytometry Systems | GKZ |
| Sep 1, 1993 | K923790 | FACSORT FLOW CYTOMETER Becton Dickinson Immunocytometry Systems | GKZ |
| Aug 5, 1993 | K924587 | SIMULTEST CD3/ANTI-HLA-DR Becton Dickinson Immunocytometry Systems | GKZ |
| Dec 29, 1989 | K890349 | SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN Becton Dickinson Immunocytometry Systems | GKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||