Medical Device Manufacturer · US , San Jose , CA

Becton Dickinson Immunocytometry Systems - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1989
21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Becton Dickinson Immunocytometry Systems Hematology

21 devices
1-21 of 21
Cleared Sep 10, 2004
BD FACS 7-COLOR SETUP BEADS
K040026 · GKZ
Hematology · 247d
Cleared Sep 10, 2004
BD FACSCANTO SYSTEM
K040725 · GKZ
Hematology · 172d
Cleared May 22, 1998
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
K980858 · GKZ
Hematology · 78d
Cleared Mar 11, 1998
MULTITEST CD3/CD8/CD45/CD4
K974360 · GKZ
Hematology · 112d
Cleared Feb 17, 1998
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
K973483 · GKZ
Hematology · 155d
Cleared Dec 01, 1997
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
K971205 · GKZ
Hematology · 244d
Cleared Nov 25, 1997
TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP
K971110 · GKZ
Hematology · 244d
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K965053 · GKZ
Hematology · 338d
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP
K970326 · GKZ
Hematology · 297d
Cleared Oct 22, 1997
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
K970742 · GKZ
Hematology · 236d
Cleared Aug 26, 1997
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
K970836 · GKZ
Hematology · 183d
Cleared Dec 12, 1996
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
K963963 · GKZ
Hematology · 71d
Cleared Feb 20, 1996
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K946055 · GKZ
Hematology · 449d
Cleared Feb 20, 1996
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
K950342 · GKZ
Hematology · 389d
Cleared Nov 20, 1995
FACS LOADER SYSTEM
K953302 · GKZ
Hematology · 129d
Cleared Aug 22, 1995
TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP
K950057 · GKZ
Hematology · 229d
Cleared Sep 30, 1994
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS
K925274 · GKZ
Hematology · 711d
Cleared Sep 09, 1994
FASCOUNT SYSTME
K933486 · GKZ
Hematology · 417d
Cleared Sep 01, 1993
FACSORT FLOW CYTOMETER
K923790 · GKZ
Hematology · 400d
Cleared Aug 05, 1993
SIMULTEST CD3/ANTI-HLA-DR
K924587 · GKZ
Hematology · 329d
Cleared Dec 29, 1989
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
K890349 · GKZ
Hematology · 339d
Filters
All21 Hematology 21