Autolyzer 800

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

510(k) Number

K841852 ↗

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 Autolyzer 800?

  The Autolyzer 800 is a laboratory instrument specifically designed to function as a differential cell counter, assisting clinicians and laboratory staff in the analysis of blood cell populations.

• How is this device classified for regulatory purposes?

  The device is classified as a Class 2 medical device under regulation number 864.5220. It received FDA 510(k) clearance on September 5, 1984, through a traditional submission pathway.

• Who is the manufacturer of the Autolyzer 800?

  The Autolyzer 800 is manufactured by Geometric Data, a division of Smithkline Corp., located in Walker, Michigan.