BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010— 510(k) K081213

Clearance details

Applicant

Bd Biosciences

Product code

Code GKZ

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

2008-04-30

Decision date

2008-08-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

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• K251249 — Tru Hematology Test2026-01-16
• K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25
• K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

• K141468 — BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)2015-02-27
• K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 6446112009-07-31
• K071141 — BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 3404022007-06-06
• K071143 — BD TRITEST CD3/CD4/CD45, MODEL 3403832007-06-06
• K062087 — BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 3389622006-09-14

Malfunction

1,205

Total

1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2090-2015 — BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.Class III·Terminated·BD Biosciences, Systems & Reagents·20150615

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081213.