BD FACS 7-COLOR SETUP BEADS— 510(k) K040026
Substantially EquivalentBecton Dickinson Immunocytometry Systems
FDA 510(k) clearance K040026 for BD FACS 7-COLOR SETUP BEADS, Substantially Equivalent on 2004-09-10. Applicant: Becton Dickinson Immunocytometry Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Immunocytometry Systems
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GKZ
view allMore clearances from Becton Dickinson Immunocytometry Systems
view all- K040725 — BD FACSCANTO SYSTEM
- K980858 — MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
- K974360 — MULTITEST CD3/CD8/CD45/CD4
- K973483 — FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
- K971205 — TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K040026
K-number listed on FDA's recall record- Z-2078-2025 — REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
- Z-2079-2025 — REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
- Z-2397-2012 — BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040026.
Data sourced from openFDA. This site is unofficial and independent of the FDA.