ANTI-HUMAN LEU-2A (CD8) PE— 510(k) K904390

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code GKZ

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

1990-09-25

Decision date

1990-12-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Franklin Lakes, NJ, US

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• K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
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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-1000-2015 — CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.Class II·Terminated·BD Biosciences, Systems & Reagents·20141219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904390.