Analyzer, 100, Bichromatic, Abbott

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780388 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

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. →