Technison Axon System

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

510(k) Number

K941156 ↗

FDA Product Code

KHS

Device Class

Class II

Regulation

21 CFR Part 862.1160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Iron -II (Fe-II) Method/Tech Chem 1(R) 1+TM System

  Class I

  FDA 510(k) K935287 Active Cleared 3 Jan 1994

• Technicon Immuno 1(R) System in-Vitro Diagnostic System

  Class I

  FDA 510(k) K950353 Active Cleared 20 Apr 1995

• Technicon H* 3 Rtc System (in-Vitro Diagnostic System)

  Class II

  FDA 510(k) K941171 Active Cleared 14 Dec 1994

• Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic System

  Class II

  FDA 510(k) K950292 Active Cleared 2 May 1995

• Creatinine (Enzymatic UV) Procedure for Technicon Systems (in Vitro Diagnostic Test System)

  Class II

  FDA 510(k) K945655 Active Cleared 5 Jan 1995

• Ck-Mb Method for the Technicon Immuno 1(R) System in-Vitro Diagnostic System

  Class II

  FDA 510(k) K950186 Active Cleared 13 Mar 1995

See all devices from Miles, Inc. →

• What clinical applications does the Technison Axon System support?

  The Technison Axon System is designed for clinical chemistry applications, specifically for measuring carbon-dioxide levels and performing biochemical assays. This makes it suitable for diagnostic testing in laboratory settings where automated biochemical analysis is required, such as monitoring electrolyte balance, acid-base status, and other metabolic parameters.

• Is the Technison Axon System reusable or single-use?

  The Technison Axon System is supplied as a reusable instrument. It is not intended for single-use, allowing laboratories to maintain cost efficiency and operational continuity over time while adhering to regulatory standards for automated biochemical analysis.

• What sterility status does the Technison Axon System have?

  The Technison Axon System is classified as non-sterile. This means it is not pre-sterilized for direct patient contact but is intended for use in controlled laboratory environments where sterility is maintained through proper cleaning and maintenance protocols.

• How many FEI numbers correspond to the Technison Axon System?

  The Technison Axon System includes multiple FEI (Facility Equipment Identifier) numbers, including 2517506, 3016438761, and several others (e.g., 3005333358, 3006198300). These identifiers correspond to various configurations or models of the system, ensuring compliance with U.S. medical device regulations and facilitating inventory management in clinical settings.

• What regulatory pathway does the Technison Axon System follow?

  The Technison Axon System is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K941156. It was determined to be substantially equivalent to a predicate device and falls under product code KHS with regulatory classification 862.1160, ensuring it meets the necessary standards for automated biochemical analysis in clinical chemistry.