Tri-Count

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

510(k) Number

K851375 ↗

FDA Product Code

JPK

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Tri-Count 7

  Class II

  FDA 510(k) K833130 Active Cleared 20 Oct 1983

• Laser-Lyse

  Class I

  FDA 510(k) K850097 Active Cleared 29 Mar 1985

• Laser-Globin

  Class II

  FDA 510(k) K850096 Active Cleared 29 Mar 1985

• Osmocel +

  Class I

  FDA 510(k) K830188 Active Cleared 1 Mar 1983

• Hemacal

  Class II

  FDA 510(k) K831306 Active Cleared 16 Jun 1983

• Osmocel 3

  Class I

  FDA 510(k) K851843 Active Cleared 30 Jul 1985

See all devices from Hematology Marketing Assoc. →

• What is the Tri-Count used for in a hematology lab?

  The Tri-Count is a quality control mixture designed specifically for hematology laboratories to verify the performance of automated blood cell counting systems. It serves as a reference standard to ensure the reliability and accuracy of hematological testing results, helping maintain consistency and precision in daily lab operations.

• Is the Tri-Count intended for single-use or reuse?

  The Tri-Count is supplied as a single-use reagent mixture. This design ensures that each use provides consistent and uncontaminated results, reducing the risk of carryover errors or degradation that could affect accuracy over multiple uses.

• What regulatory approval does the Tri-Count hold?

  The Tri-Count is cleared by the FDA under the 510(k) pathway with clearance number K851375. It is classified as a Class II medical device and falls under the regulatory category 864.8625, which pertains to hematology quality control mixtures.

• How should the Tri-Count be stored to maintain stability?

  The Tri-Count must be stored according to the manufacturer’s instructions to preserve its stability and efficacy. Proper storage conditions typically include protection from extreme temperatures, light exposure, and contamination, as outlined in the accompanying documentation.

• Can the Tri-Count be used with any automated hematology analyzer?

  The Tri-Count is intended for use in automated hematology analyzers that require a quality control reagent for blood cell counting. While it is designed to be compatible with most systems in this category, it is essential to verify compatibility with the specific analyzer model in use, as performance may vary slightly depending on the equipment.