Cell-Dyn 3000 Multi-Parameter Hematology Analyer

• • Terminated Z-1198-2007 FDA Unclassified (pre-2012) ·initiated 11 May 2007

  The product failed electrostatic discharge testing, which could result in product failure.

510(k) Number

K890491 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• 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

• Cell-Dyn 100 Whole Blood Platelet

  Class II

  FDA 510(k) K840170 Active Cleared 2 Mar 1984

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