ANTI-HUMAN LEU-3A (CD4) FITC— 510(k) K900802

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

1990-02-20

Decision date

1990-05-15

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-2817-2015 — CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).Class III·Terminated·Becton, Dickinson and Company, BD Biosciences·20150827

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K900802.