Medicount Deka Hematology Analyzer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K942525 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Singul-Xr Rp Non Screen Med. Film

  Class I

  FDA 510(k) K834611 Active Cleared 21 Feb 1984

• Wilcor-Xr Rp-Og Medical Film

  Class I

  FDA 510(k) K834612 Active Cleared 27 Feb 1984

• Wilcor-Xr Rp Medical Film

  Class I

  FDA 510(k) K834613 Active Cleared 5 Mar 1984

• Wilcor-Xr Rp-L Medical Film

  Class I

  FDA 510(k) K834614 Active Cleared 5 Mar 1984

• What is the Medicount Deka Hematology Analyzer used for?

  The Medicount Deka Hematology Analyzer is designed for automated counting, classification, and flagging of mature and immature hematopoietic cells in blood samples. It supports hematological diagnostics by identifying and analyzing formed blood elements, including abnormal cells, to assist clinicians in diagnosing conditions like anemia, infections, or malignancies. This functionality is critical for accurate differential cell counts in clinical laboratory settings.

• Is the Medicount Deka Hematology Analyzer reusable or single-use?

  The Medicount Deka Hematology Analyzer is a reusable device. Like other automated hematology analyzers, it requires regular maintenance, calibration, and cleaning to ensure consistent performance and accuracy over time. Reusability helps reduce waste and operational costs in clinical settings.

• Does the Medicount Deka Hematology Analyzer require any special storage conditions?

  The device data does not specify special storage conditions beyond standard environmental requirements for medical equipment. It should be stored in a clean, dry environment, protected from extreme temperatures, humidity, and direct sunlight. Proper maintenance and calibration procedures should also be followed to preserve functionality, as outlined in the manufacturer’s instructions.

• What regulatory approval does the Medicount Deka Hematology Analyzer hold?

  The Medicount Deka Hematology Analyzer holds an FDA 510(k) clearance (K942525), confirming it is substantially equivalent to a legally marketed predicate device for automated differential cell counters. This clearance is specific to its intended use in clinical laboratories for hematological analysis. No additional regulatory details regarding sterility or MRI safety are mentioned in the available data.

• How does the Medicount Deka Hematology Analyzer differ from other hematology analyzers?

  The Medicount Deka Hematology Analyzer is distinguished by its automated capability to classify and flag both mature and immature hematopoietic cells, including abnormal cells, which aids in comprehensive hematological diagnostics. It falls under FDA classification 864.5220 for automated differential cell counters and has been cleared via a traditional 510(k) pathway. While other analyzers may focus on specific cell types or parameters, this device’s design emphasizes broad differential analysis for clinical decision-making.