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Calcium:Arsenazo III

by Amresco, Inc.

510(k) K902476

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902476 Date17 Jul 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Calcium:Arsenazo III is an azo dye used in clinical chemistry for the determination of calcium. It is a chemical reagent designed to form a colored complex with calcium ions, enabling spectrophotometric measurement.

The device is supplied as a reagent for in vitro diagnostic use. It is classified as a Class II medical device under FDA regulation 862.1145 with product code CJY, and received traditional 510(k) clearance (K902476) on July 17, 1990, based on substantial equivalence to a predicate device.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Calcium:Arsenazo III used for?

    Calcium:Arsenazo III is used in clinical chemistry for the determination of calcium, forming a colored complex with calcium ions for spectrophotometric measurement.

  • How is Calcium:Arsenazo III supplied?

    Calcium:Arsenazo III is supplied as a reagent for in vitro diagnostic use.

  • What type of medical device is Calcium:Arsenazo III?

    Calcium:Arsenazo III is classified as a Class II medical device under FDA regulation 862.1145 with product code CJY.