Picoscal Blood Cell Counter PS-4

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K842140 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Digital Radiography System

  Not classified

  FDA 510(k) K827289 Active Cleared 21 Apr 1982

• Picoscale Blood Cell Counter, Model Ps-5

  Class II

  FDA 510(k) K860166 Active Cleared 4 Apr 1986

• Sickle-Check

  Class II

  FDA 510(k) K820037 Active Cleared 4 Feb 1982

• Laser-Cal

  Class II

  FDA 510(k) K811063 Active Cleared 1 Jul 1981

• Lyme-Check(Tm) Test Kit

  Class II

  FDA 510(k) K896378 Active Cleared 5 Nov 1991

• Resubmitted Ebv/Igm-Check Test Kit

  Class I

  FDA 510(k) K890639 Active Cleared 20 Jun 1989

See all devices from Diagnostic Technology, Inc. →

• What types of blood components can the PICOSCAL Blood Cell Counter PS-4 measure, and how does it determine these values?

  The PICOSCAL Blood Cell Counter PS-4 measures red blood cells, white blood cells, and platelets by enumerating and sizing blood cells and particles in suspension using either electrical impedance or optical detection. It also provides quantitative measurements of hemoglobin and hematocrit, while calculating red cell indices like MCV, MCH, and MCHC as part of its functionality.

• Is the PICOSCAL Blood Cell Counter PS-4 a single-use or reusable device, and what maintenance is required?

  The PICOSCAL Blood Cell Counter PS-4 is a reusable device, meaning it is designed for repeated use in clinical hematology laboratories. Proper calibration and maintenance are required to ensure accurate and reliable operation, as outlined in the manufacturer’s instructions.

• What storage conditions should be followed for the PICOSCAL Blood Cell Counter PS-4, and how is it typically supplied?

  The PICOSCAL Blood Cell Counter PS-4 should be stored and handled according to the manufacturer’s guidelines to maintain performance. It can be supplied either sterile or non-sterile, depending on the specific configuration or model variant, though this detail should be confirmed with the manufacturer.

• What regulatory pathway was followed for FDA clearance of the PICOSCAL Blood Cell Counter PS-4, and what classification does it hold?

  The PICOSCAL Blood Cell Counter PS-4 was cleared through the FDA’s 510(k) pathway under the product code GKL, classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device and falls under the regulatory category 21 CFR 864.5200.