Coulter Z2 Analyzer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K991070 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coulter Albumin Reagent

  Class II

  FDA 510(k) K901268 Active Cleared 30 May 1990

• Coulter Ck (Creatine Kinase) Reagent

  Class II

  FDA 510(k) K901267 Active Cleared 23 May 1990

• Coulter Hdl - Cholesterol Reagent

  Class I

  FDA 510(k) K902174 Active Cleared 31 Jul 1990

• Coulter Total Bilirubin Reagent

  Class II

  FDA 510(k) K901266 Active Cleared 25 Apr 1990

• Coulter Linearity Control

  Class II

  FDA 510(k) K955334 Active Cleared 8 Feb 1996

• Immuno-Trol Control Cells

  Class II

  FDA 510(k) K984216 Active Cleared 16 Mar 1999

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