Amylase, Calcium, Chloride & Triglycerides on Chem 1

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K863719 ↗

FDA Product Code

CIJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

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. →

• What is the AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 device used for?

  This device is a saccharogenic amylase test system designed for clinical chemistry use. It measures amylase, calcium, chloride, and triglycerides in vitro using the Chem 1 analyzer platform, enabling laboratories to perform these specific biochemical assays as part of routine diagnostic testing.

• How is the AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 supplied and what is its intended use?

  The device is supplied as a reagent system for in vitro diagnostic use in clinical laboratories. It is intended for use with the Chem 1 analyzer platform to quantitatively measure amylase, calcium, chloride, and triglycerides in patient specimens outside the body, supporting diagnostic evaluation in clinical chemistry settings.

• What regulatory pathway was used for the AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 device and when was it cleared?

  The device received FDA 510(k) clearance under submission K863719 on November 13, 1986. It was found substantially equivalent to a predicate device and is classified as a Class II medical device under product code CIJ, which corresponds to saccharogenic amylase test systems in clinical chemistry.