Hematrak Abnormal Recognition

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

510(k) Number

K791041 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hemastain Wright Stain

  Not classified

  FDA 510(k) K760486 Active Cleared 30 Aug 1976

• Hemastain Fixative

  Class I

  FDA 510(k) K760485 Active Cleared 30 Aug 1976

• Blood-Smearing Instrument (Miniprep Tm)

  Class I

  FDA 510(k) K760007 Active Cleared 3 Sep 1976

• Hematrak Model 480

  Class II

  FDA 510(k) K790816 Active Cleared 17 Jul 1979

• Hematrak

  Class II

  FDA 510(k) K770680 Active Cleared 1 Jul 1977

• Hematrak Rbc Morphology

  Class II

  FDA 510(k) K761207 Active Cleared 18 Oct 1977

See all devices from Geometric Data, Div. Smithkline Corp. →

• What is the HEMATRAK Abnormal Recognition device used for?

  The HEMATRAK Abnormal Recognition is a hematology device designed for the recognition of abnormal cells in laboratory settings. It is classified as a Counter, Differential Cell device and is intended for use in hematology laboratories to assist in cell identification and analysis.

• Is the HEMATRAK Abnormal Recognition device single-use or reusable?

  The device information does not specify whether the HEMATRAK Abnormal Recognition is designed for single-use or multiple reuse. This detail is not provided in the available documentation, so users should consult the manufacturer's instructions for specific guidance on usage and disposal protocols.

• What regulatory approvals does the HEMATRAK Abnormal Recognition have?

  The HEMATRAK Abnormal Recognition received FDA 510(k) clearance with number K791041 on September 4, 1979. It is classified as a Class II device with product code GKZ and is intended for laboratory use. The device is manufactured by Geometric Data, Div. Smithkline Corp.

• What are the specifications of the HEMATRAK Abnormal Recognition device?

  The HEMATRAK Abnormal Recognition is a hematology device classified as a Counter, Differential Cell device. It has product code GKZ and is a Class II device. The device is designed for laboratory use and received FDA clearance through the traditional 510(k) pathway, with a decision description of 'Substantially Equivalent'.