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

Becton Dickinson Immunocytometry Systems has 21 FDA 510(k) cleared hematology devices. Based in San Jose, US.

Historical record: 21 cleared submissions from 1989 to 2004.

Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

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
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