Counter, Blood Cell & Hematocrit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770034 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

See all devices from Mallinckrodt Critical Care →

• What is the Blood Cell & Hematocrit Counter used for?

  This automated device is used to count red blood cells, white blood cells, and blood platelets from a patient's peripheral blood sample. It can also measure hemoglobin or hematocrit and calculate or measure red cell indices for hematology applications.

• How is the Blood Cell & Hematocrit Counter supplied?

  The device is supplied by Mallinckrodt Critical Care. The product information does not specify whether it is single-use or reusable, nor does it provide details about sterility or storage conditions.

• What is the regulatory status of this device?

  The Blood Cell & Hematocrit Counter is authorized under FDA 510(k) clearance K770034 with product code GKL. It is classified as a Class II device and is intended for use in hematology applications.

• What are the specifications of this blood cell counter?

  This device is described as a fully-automated or semi-automated cell counter that can count red blood cells, white blood cells, and platelets, as well as measure hemoglobin or hematocrit. It may also calculate or measure red cell indices. The device received FDA clearance in 1977.