Technicon H6000 Hematology System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K801155 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Technicon H6000 Hematology System used for?

  The Technicon H6000 Hematology System is an automated cell counter used for hematology testing in clinical laboratory settings, as it performs automated counting of blood cells to support diagnostic analysis.

• How is the Technicon H6000 Hematology System supplied or configured for use?

  The system is supplied as a complete automated hematology analyzer designed for installation and operation in clinical laboratories, integrating sample processing, cell counting, and result reporting based on its 1980 FDA 510(k) cleared configuration.

• Is the Technicon H6000 Hematology System intended for single-use or reusable components?

  The Technicon H6000 Hematology System is a reusable laboratory instrument; while it processes disposable samples, the analyzer itself is designed for repeated use in clinical environments after proper maintenance and calibration.

• What regulatory pathway was used for the Technicon H6000 Hematology System?

  The Technicon H6000 Hematology System received FDA 510(k) clearance under submission K801155 on June 9, 1980, demonstrating substantial equivalence to a legally marketed predicate device for automated cell counting in hematology.