Technicon Ra-1000 System Analyte Theophylline

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K852573 ↗

FDA Product Code

KLS

Device Class

Class II

Regulation

21 CFR Part 862.3880

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Autozyme Immobilized Enzyme Coil

  Class II

  FDA 510(k) K771384 Active Cleared 22 Aug 1977

• Sma Microlyzer

  Class I

  FDA 510(k) K761342 Active Cleared 1 Feb 1977

• Ra System, Analyte Serum Amylase (30C and 37C)

  Class II

  FDA 510(k) K871269 Active Cleared 13 Apr 1987

• Technicon Testpoint(Tm) Ligand Control

  Class I

  FDA 510(k) K900717 Active Cleared 26 Apr 1990

• Chem 1 Clinical Analyzer Urine Urea Nitrogen

  Class II

  FDA 510(k) K901123 Active Cleared 10 May 1990

• Technicon H6000 Hematology System

  Class II

  FDA 510(k) K801155 Active Cleared 9 Jun 1980

See all devices from Technicon Instruments Corp. →