Becton Dickinson Immunocytometry Systems

San Jose, CA, US

Becton Dickinson Immunocytometry Systems appears in FDA device records in San Jose, CA. FDA records list 21 510(k) clearances between 1989-12-29 and 2004-09-10, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 21
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 21 510(k) clearances for Becton Dickinson Immunocytometry Systems between 1989 and 2004. The busiest year on record is 1997, with 6. The most recent is 2004, with 2.

Clearances by year, as a table

510(k) clearance decisions for Becton Dickinson Immunocytometry Systems, by decision year
Year	Clearances
1989	1
1993	2
1994	2
1995	2
1996	3
1997	6
1998	3
2004	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K040725	BD FACSCANTO SYSTEM	GKZ	Substantially Equivalent	2004-09-10
K040026	BD FACS 7-COLOR SETUP BEADS	GKZ	Substantially Equivalent	2004-09-10
K980858	MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION	GKZ	Substantially Equivalent	1998-05-22
K974360	MULTITEST CD3/CD8/CD45/CD4	GKZ	Substantially Equivalent	1998-03-11
K973483	FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET	GKZ	Substantially Equivalent	1998-02-17
K971205	TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	Substantially Equivalent	1997-12-01
K971110	TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	Substantially Equivalent	1997-11-25
K970326	TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	Substantially Equivalent	1997-11-21
K965053	TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	Substantially Equivalent	1997-11-21
K970742	TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES	GKZ	Substantially Equivalent	1997-10-22
K970836	TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS	GKZ	Substantially Equivalent	1997-08-26
K963963	MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS	GKZ	Substantially Equivalent	1996-12-12
K950342	TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP	GKZ	Substantially Equivalent	1996-02-20
K946055	TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP	GKZ	Substantially Equivalent	1996-02-20
K953302	FACS LOADER SYSTEM	GKZ	Substantially Equivalent	1995-11-20
K950057	TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP	GKZ	Substantially Equivalent	1995-08-22
K925274	AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS	GKZ	Substantially Equivalent	1994-09-30
K933486	FASCOUNT SYSTME	GKZ	Substantially Equivalent	1994-09-09
K923790	FACSORT FLOW CYTOMETER	GKZ	Substantially Equivalent	1993-09-01
K924587	SIMULTEST CD3/ANTI-HLA-DR	GKZ	Substantially Equivalent	1993-08-05
K890349	SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN	GKZ	Substantially Equivalent	1989-12-29

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

GKZCounter, Differential Cell

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain