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Optional Total Ca-Module For IL 504/508

by Instrumentation Laboratory CO

510(k) K812872

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812872 Date26 Oct 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
CIS
Device class
Class II
Regulation
21 CFR Part 862.1100
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Optional Total Ca-Module for IL 504/508 is a clinical chemistry device designed for use with the IL 504 and IL 508 systems. It utilizes hydrazone colorimetry to facilitate the measurement of total calcium levels in clinical samples.

This device is manufactured by Instrumentation Laboratory CO and has received FDA 510(k) clearance under the traditional submission process. It is classified as a class 2 medical device under regulation number 862.1100.

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Questions

AI-generated answers, 22 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 the primary function of the Optional Total Ca-Module?

    This module is designed to facilitate the measurement of total calcium levels within clinical samples. It is specifically engineered for integration with the IL 504 and IL 508 clinical chemistry systems.

  • What analytical method does this module use?

    The device utilizes hydrazone colorimetry to perform its analysis. This chemical method allows the IL 504 and IL 508 systems to quantify total calcium concentrations in the provided samples.

  • What is the regulatory status of this device?

    The Optional Total Ca-Module for IL 504/508 has received FDA 510(k) clearance under the traditional submission process. It is classified as a class 2 medical device under regulation number 862.1100.