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

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

510(k) Number

K935287 ↗

FDA Product Code

JIY

Device Class

Class I

Regulation

21 CFR Part 862.1410

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• 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

• Technison Axon System

  Class II

  FDA 510(k) K941156 Active Cleared 26 Apr 1994

See all devices from Miles, Inc. →