VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT— 510(k) K940003

Name: FDA 510(k) clearance K940003
Creator: U.S. Food and Drug Administration
Published: 1995-10-19

Substantially Equivalent

Buckman Co., Inc.

FDA 510(k) clearance K940003 for VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT, Substantially Equivalent on 1995-10-19. Applicant: Buckman Co., Inc.. Device class: 2.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1994-01-03
Decision date: 1995-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

view all

K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
K243348 — Athelas Home2026-02-06
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

More clearances from Buckman Co., Inc.

view all

K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM1998-06-25
K974641 — FUTURELASE 3000/3002 ERBIUM LASER SYSTEM1998-06-08
K964252 — ORTHOCHUCK1997-05-27
K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM1997-01-16
K960451 — WEBB-MORLEY SPINE SYSTEM1996-04-18

Adverse events under product code GKZ

product code GKZ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.