Para Tech for Technicon H-1

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K896154 ↗

FDA Product Code

JCN

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Streck Laboratories, Inc. →

• What is the Para Tech for Technicon H-1 used for?

  The Para Tech for Technicon H-1 is a quality control reagent designed specifically for Technicon H-1 cell counters. It provides standardized reference values to evaluate and maintain the performance of these hematology analyzers, ensuring precise measurement of both normal and abnormal blood cell parameters. This helps laboratories validate their instruments’ accuracy and reliability during routine calibration and maintenance.

• How is the Para Tech for Technicon H-1 supplied and intended for use?

  This reagent is supplied as a liquid and is intended for single-use in laboratory settings where Technicon H-1 cell counters are utilized. It is not meant for repeated use or reuse; each vial is designed for one calibration or quality control check to ensure consistency and accuracy in hematology testing.

• Is the Para Tech for Technicon H-1 sterile?

  The available data does not specify whether the Para Tech for Technicon H-1 is sterile. Since it is a quality control reagent for in vitro diagnostic use, it should be handled under standard laboratory aseptic practices to prevent contamination of the cell counter. Always follow manufacturer guidelines for preparation and use.

• What regulatory pathway does the Para Tech for Technicon H-1 follow?

  The Para Tech for Technicon H-1 was cleared through the FDA’s Traditional 510(k) pathway under the Hematology (HE) Advisory Committee. It was determined to be substantially equivalent to a predicate device and classified as a Class II medical device under 21 CFR 864.8625. This clearance ensures it meets regulatory standards for quality control reagents in hematology.

• Are there different sizes or models of the Para Tech for Technicon H-1?

  The provided data does not specify multiple sizes or models for the Para Tech for Technicon H-1. It is listed as a single product intended for Technicon H-1 cell counters. For exact specifications, including packaging or volume, refer to the manufacturer’s documentation or contact Streck Laboratories directly.