Emit 2000 Quindine Assay Quididine Calibrators

• • Ongoing Z-2975-2026 FDA Class II ·initiated 13 Jul 2026

  Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

510(k) Number

K922913 ↗

FDA Product Code

LBZ

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• C-Reactive Protein Control

  Class II

  FDA 510(k) K821412 Active Cleared 22 Jul 1982

• Ethyl Alcohol Serum Calibrator

  Class II

  FDA 510(k) K810466 Active Cleared 6 Mar 1981

• Micro Trak Xl System

  Class I

  FDA 510(k) K921747 Active Cleared 1 Oct 1992

• Syva Solid Phase Columns System Ii

  Class I

  FDA 510(k) K861392 Active Cleared 13 Jun 1986

• Modif. of Emit Cad Disopyramide Assay

  Class II

  FDA 510(k) K833623 Active Cleared 8 Dec 1983

• Emit Auto Cortisol Assay

  Class II

  FDA 510(k) K800245 Active Cleared 3 Mar 1980

See all devices from Syva Co. →