Irma Blood Analysis System with Optional Lifescan Surestep Pro Blood Glucose Module

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K974396 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Irma Blood Analysis System

  Class II

  FDA 510(k) K945240 Active Cleared 5 Jan 1995

• Trendcare Calibrator Model Scu 7007

  Class II

  FDA 510(k) K983198 Active Cleared 23 Nov 1999

• Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite Ms

  Class II

  FDA 510(k) K980380 Active Cleared 14 Jul 1999

• Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System

  Class II

  FDA 510(k) K972314 Active Cleared 19 Dec 1997

• Irma Sl Blood Analysis System Gl Cartridge

  Class I

  FDA 510(k) K011586 Active Cleared 16 Nov 2001

• Irma Sl Blood Analysis System Lactate Cartridge

  Class I

  FDA 510(k) K013938 Active Cleared 28 Jan 2002

See all devices from Diametrics Medical, Ltd. →