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Il Test Calcium

by Instrumentation Laboratory CO

510(k) K931362

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 NumberK931362 Date1 Feb 1994ClearedStatusActive

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  • Withdrawn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
CIC
Device class
Class II
Regulation
21 CFR Part 862.1145
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 IL TEST CALCIUM is a device classified as Cresolphthalein Complexone, Calcium, intended for clinical chemistry applications. It is designed to measure calcium levels in biological samples, supporting diagnostic and monitoring processes in healthcare settings.

The device is supplied as a single-use product and is not reusable. It requires proper storage conditions and is regulated under FDA 510(k) clearance. The product code is CIC, and it falls under Class II - Special Controls.

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Questions

AI-generated answers, 26 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 IL TEST CALCIUM used for?

    The IL TEST CALCIUM is a clinical chemistry device designed to measure calcium levels in biological samples, supporting diagnostic and monitoring processes in healthcare settings.

  • Is the IL TEST CALCIUM reusable?

    No, the IL TEST CALCIUM is supplied as a single-use product and is not reusable.

  • What are the storage requirements for the IL TEST CALCIUM?

    The device requires proper storage conditions to maintain its integrity, though specific storage details are not provided in the device data.

  • What is the regulatory status of the IL TEST CALCIUM?

    The IL TEST CALCIUM is regulated under FDA 510(k) clearance and falls under Class II - Special Controls.