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Single Reagent Calcium for Demand Analyzer

by Advanced Biomedical Methods, Inc. 510(k)

Active United States

510(k) K880949

Overview

This device is a single reagent calcium test for use with demand analyzers, based on the Arsenazo III method for the quantitative determination of calcium in automated clinical chemistry systems. It is classified as an Azo Dye, Calcium reagent under FDA device classification and is intended for in vitro diagnostic use.

The reagent is supplied as a single-reagent format, offering stability and resistance to common interferences in calcium measurement. It received traditional 510(k) clearance (K880949) on April 5, 1988, and is regulated under FDA regulation number 862.1145 for clinical chemistry devices.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880949 Date5 Apr 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CJY
Device Class
Class II
Regulation
21 CFR Part 862.1145
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER used for?

    It is used for the quantitative determination of calcium in automated clinical chemistry systems via the Arsenazo III method, providing a single-reagent format designed for stability and resistance to common interferences in calcium measurement on demand analyzers.

  • How is the SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER supplied and stored?

    The reagent is supplied as a single-reagent format, which enhances stability and resistance to common interferences; specific storage conditions are not detailed in the provided data, but as an in vitro diagnostic reagent, it should be stored according to manufacturer labeling to maintain performance until expiration.

  • Is the SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER intended for single-use or reuse?

    As an in vitro diagnostic reagent supplied in a single-reagent format for use with demand analyzers, it is intended for single-use per test cycle; reuse is not indicated or supported by the device description, which emphasizes its role as a consumable reagent for automated clinical chemistry systems.