Hematrak Model 125

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

510(k) Number

K770701 ↗

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 primary function of the Hematrak Model 125?

  The Hematrak Model 125 is a differential cell counter designed for use in hematology applications. Its primary purpose is to assist clinical professionals in the analysis of blood cell populations.

• What is the regulatory status of this device?

  The Hematrak Model 125 is classified as a Class 2 medical device. It received FDA 510(k) clearance on June 3, 1977, under submission number K770701, and is regulated under 21 CFR 864.5220.

• Who is the manufacturer of the Hematrak Model 125?

  This device is manufactured by Geometric Data, which is a division of Smithkline Corp. The company is located in McHenry, Illinois.