MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632— 510(k) K022161

Name: FDA 510(k) clearance K022161
Creator: U.S. Food and Drug Administration
Published: 2002-07-29

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K022161 for MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632, Substantially Equivalent on 2002-07-29. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2002-07-03
Decision date: 2002-07-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K022161

K-number listed on FDA's recall record

Z-3113-2017 — Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, or any other test that aids in diagnosing an abnormalityClass II·Terminated·Beckman Coulter Inc.·20170626

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022161.

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