Cell-Dyn 400 Hematology Analyzer

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

Full name

Cell-Dyn 400 Hemotology Analyzer

510(k) Number

K831368 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Cell-Dyn 3000 Multi-Parameter Hematology Analyer

  Class II

  FDA 510(k) K890491 Active Cleared 18 Apr 1989

• Model 340 Spectrophotometer

  Class I

  FDA 510(k) K822720 Active Cleared 8 Oct 1982

• Cell Dyn 800 Hematology Analyzer

  Class II

  FDA 510(k) K803218 Active Cleared 9 Jun 1981

• Cell-Dyn 2000 Automated Multi-Parameter Hematology

  Class II

  FDA 510(k) K852371 Active Cleared 17 Sep 1985

• Cell-Dyn Rapid-Lyse and Hemogloblin

  Class II

  FDA 510(k) K881242 Active Cleared 21 Apr 1988

• Cell-Dyn Brand Hematology Reagents

  Class II

  FDA 510(k) K852372 Active Cleared 3 Sep 1985

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• What is the primary function of the Cell-Dyn 400 Hematology Analyzer?

  The Cell-Dyn 400 is an automated particle counter designed to perform multi-parameter hematological analysis. It is intended for use in clinical laboratories to assist with diagnostic testing.

• What is the regulatory status of this device?

  The Cell-Dyn 400 Hematology Analyzer is regulated under FDA 510(k) clearance K831368. It is classified as an automated particle counter, which falls under regulation number 864.5200.

• In what type of environment is this analyzer intended to be used?

  This device is designed for use in clinical laboratory settings. It is suitable for laboratories with varying testing volumes, providing automated cell counting capabilities for hematology applications.