Hemochron Verigy System/Factor Vi Qualify System

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

510(k) Number

K940957 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hemochron(R) Kact

  Class II

  FDA 510(k) K913861 Active Cleared 18 Oct 1991

• Hemochron Jr Generation II, Hemochron Jr Signature

  Class II

  FDA 510(k) K974799 Active Cleared 7 Jul 1998

• Hemochron Citrate Aptt

  Class II

  FDA 510(k) K972831 Active Cleared 20 Nov 1997

• Protime Microcoagulation System

  Class II

  FDA 510(k) K951072 Active Cleared 27 Oct 1995

• Tenderfoot

  Class II

  FDA 510(k) K883968 Active Cleared 1 Dec 1988

• Prothrombin Time (Pt) by Hemochron, Modification

  Class II

  FDA 510(k) K911995 Active Cleared 17 Jul 1991

See all devices from International Technidyne Corp. →

• What is the Hemochron Verigy System/Factor Vi Qualify System used for?

  The Hemochron Verigy System/Factor Vi Qualify System is a multipurpose system designed for in vitro coagulation studies in laboratory settings. It is specifically intended for analyzing coagulation factors to support diagnostic testing.

• How is the Hemochron Verigy System supplied and what models are available?

  The system is manufactured by International Technidyne Corp. and is supplied with various model numbers. Each model is designed for in vitro diagnostic use, allowing laboratories to select the appropriate configuration for their specific coagulation testing needs.

• What is the regulatory status of the Hemochron Verigy System?

  The Hemochron Verigy System/Factor Vi Qualify System received FDA 510(k) clearance on October 18, 1994. It is classified as a Class II device under special controls regulation 864.5425, with product code JPA, indicating it meets specific safety and effectiveness requirements for laboratory use.

• Is the Hemochron Verigy System reusable or single-use?

  The device is designed for in vitro diagnostic use in laboratory settings. While the system itself may be reusable for multiple tests, the specific components or cartridges used with the system may have different usage instructions that should be followed according to the manufacturer's guidelines.