Immpulse Gentamicin Assay Reagents

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K841162 ↗

FDA Product Code

LCQ

Device Class

Class II

Regulation

21 CFR Part 862.3450

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Immpulse Theophylline Assay Reagents

  Class II

  FDA 510(k) K840758 Active Cleared 4 Apr 1984

• Immpulse System

  Class I

  FDA 510(k) K834070 Active Cleared 23 Mar 1984

• Immpulse T4 Assay Reagents

  Class II

  FDA 510(k) K840852 Active Cleared 18 Apr 1984

• Immpulse Tobramycin Assay Reagents

  Class II

  FDA 510(k) K840847 Active Cleared 4 Apr 1984

• Immpulse Amikacin Assay Reagents

  Class II

  FDA 510(k) K841161 Active Cleared 2 May 1984

• Immpulse Tbc Assay Reagents

  Class II

  FDA 510(k) K840853 Active Cleared 1 Apr 1984