Technicon Dpa-1 Immunoglobulin M

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

510(k) Number

K883493 ↗

FDA Product Code

DFL

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

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. →