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

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K950186 ↗

FDA Product Code

JHW

Device Class

Class II

Regulation

21 CFR Part 862.1215

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

• Technison Axon System

  Class II

  FDA 510(k) K941156 Active Cleared 26 Apr 1994

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