Rdw Parameter For The Technicon H6000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K834026 ↗

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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  FDA 510(k) K761342 Active Cleared 1 Feb 1977

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• Technicon H6000 Hematology System

  Class II

  FDA 510(k) K801155 Active Cleared 9 Jun 1980

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• What is the primary function of the RDW Parameter for the Technicon H6000?

  This device serves as an automated particle counter component specifically designed to integrate with the Technicon H6000 hematology system. Its purpose is to facilitate the counting and analysis of cells within hematology laboratory applications.

• What is the regulatory classification of this device?

  The RDW Parameter for the Technicon H6000 is classified as a Class 2 medical device under regulation number 864.5200. It received FDA 510(k) clearance via the traditional pathway on January 30, 1984, under submission number K834026.

• Which medical specialty is this device associated with?

  This device is categorized under the hematology advisory committee. It is designed to support hematology workflows by providing automated particle counting capabilities as part of the broader Technicon H6000 system.